Microbiologist Resume Samples
4.7
(102 votes) for
Microbiologist Resume Samples
The Guide To Resume Tailoring
Guide the recruiter to the conclusion that you are the best candidate for the microbiologist job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.
Craft your perfect resume by picking job responsibilities written by professional recruiters
Pick from the thousands of curated job responsibilities used by the leading companies
Tailor your resume & cover letter with wording that best fits for each job you apply
Resume Builder
Create a Resume in Minutes with Professional Resume Templates
CHOOSE THE BEST TEMPLATE
- Choose from 15 Leading Templates. No need to think about design details.
USE PRE-WRITTEN BULLET POINTS
- Select from thousands of pre-written bullet points.
SAVE YOUR DOCUMENTS IN PDF FILES
- Instantly download in PDF format or share a custom link.
DR
D Raynor
Drake
Raynor
307 Schmidt Unions
Los Angeles
CA
+1 (555) 136 8138
307 Schmidt Unions
Los Angeles
CA
Phone
p
+1 (555) 136 8138
Experience
Experience
San Francisco, CA
Microbiologist
San Francisco, CA
Pfeffer-Hilll
San Francisco, CA
Microbiologist
- Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation. Keeps supervisor informed of work status
- Perform standardized tests using general laboratory equipment. Performs routine care of designated test equipment and work area
- Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation
- Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release
- Create and revise forms, work instructions or SOP’s with guidance
- Provide recommendations and feedback on testing results to management
- Follow policies and assists in the development of new procedures and/or documents
New York, NY
Associate Microbiologist
New York, NY
Kunde, Weimann and Frami
New York, NY
Associate Microbiologist
- Assists in developing, writing and updating, laboratory SOP’s and approved procedures
- Perform instrumentation work
- Be a point of contact for suppliers for new process development, quality issues and process improvements for assigned projects
- Perform diagnostics and reporting work
- Assist in provide training on molecular biology and/or microbiology topics including sample collection/analysis/threat-agent production
- Duties may be executed in a CONUS or OCONUS laboratory and include performing analyses of samples that have been collected
- Perform routine cleaning of work areas
present
Boston, MA
Senior Microbiologist
Boston, MA
Mayer, Breitenberg and Ratke
present
Boston, MA
Senior Microbiologist
present
- Develop or assist in developing experimental designs and test plans
- Schedules and prioritize work for staff and develop training and analyst qualification programs to perform assays under cGMPs
- Provide technical support to R&D for new product development
- Perform laboratory work on weekends and holidays on a rotating basis with other members of the department
- Prepare in-depth risk assessment for all new product development and provide Microbiology expert summary for Regulatory submission
- Provide technical assistance to external and internal customers regarding microbiological enquiries
- Lead and participate in the development and improvement of processes for existing and new products
Education
Education
Bachelor’s Degree in Microbiology
Bachelor’s Degree in Microbiology
New York University
Bachelor’s Degree in Microbiology
Skills
Skills
- Excellent oral & written communication and presentation skills, with ability to communicate confidently and build strong networks across the organization
- Strong ability to balance multiple priorities with excellent time management skills
- Acts quickly and decisively; able to make tough calls
- Technical knowledge and experience in related field and in using quality management methods and tools
- Able to maintain good turnaround time (TAT) and on time delivery (OTD)
- Able to maintain highest quality standard all the time
- Strong attention to detail
- Ability to change directions, remain flexible and respond quickly
- Working knowledge of cGMPs as applicable to laboratory environment
- The candidate will be expected to quickly develop a working knowledge on predictive modelling techniques and large data set analysis
15 Microbiologist resume templates
Read our complete resume writing guides
1
Plant Microbiologist Resume Examples & Samples
- Bachelor's Degree in Microbiology or in a related science
- Knowledge of industry/regulatory standards and methods and sound understanding of mathematical concepts
- Ability to read, analyze and interpret scientific methods and data, writing reports, training procedures and SOPs
- 1+ year of Plant Microbiology experience
2
Microbiologist Resume Examples & Samples
- 5+ years of Microbiology experience
- Doctorate in Microbiology
- NYS Department of Health Microbiology CQ certification/license
- ASCP eligible
3
Microbiologist Resume Examples & Samples
- Responsible for maintaining up-to-date knowledge of all current relevant worldwide regulatory requirements that relate to products manufactured
- Responsible for the supervision of Laboratory Assistants
- Responsible for the setting of appropriate microbiological quality standards for all products and ensuring that these standards are applied uniformly across the site
- Responsible for ensuring compliance with all sterilisation and environmental monitoring requirements
- Responsible for dose establishment, dose audits, dose mapping and preparing cycle time charts on a weekly basis
- Develop appropriate technical awareness to perform pre-release assessment of product for shipment
- Act as microbiological technical specialist
- Three to five years experience in a healthcare industry in a similar role
- Radiation and sterilization experience would be advantageous
- Excellent interpersonal, communication and team building skills
- Must be computer literate with knowledge of Microsoft Office software an advantage
4
Microbiologist Resume Examples & Samples
- Lead microbiology capability development initiatives for bottlers, suppliers and third party laboratoty
- Provide training and guidance to plants in Eurasia region on microbiology, Lab operations and testing
- Provide support to BU in developing Corrective and Preventive actions on relevant issues
- Develop capability and implement new microbiology testing techniques as needed at EASC
- Perform microbiology tesing of beverages/ ingredients at EASC
- Support Risk Assessments for bottling plant
- Build up network of microbiologists in the region to further strength their existing competency
- Provide support to bottling partners on HACCP/ food safety
- Ensure functioning of microbiology lab as per ISO 17025 and GQAS norms
- Ensuring the microbiology laboratory is suitably equipped, resourced and maintained to perform all necessary testing required by Company specifications and requirements
- Providing appropriate consultations for microbiological inquiries and concerns. HelpBU and bottlers on micro test protocol design. This may include support to new product introduction, particularly sensitive beverages
- Provide on-site training when requested by BUs
- Support day-to -day functioning of EASC through basic understanding of beverage analysis and beverage parameters
- Support roll out and participate in Plant chemist training programs
- Conduct Internal audits for EASC as required
- Participate in third party lab assessments as needed
- Participate in proficiency testing as required
- Investigative mindset, analytical & logical thinking
- Understanding of problem solving techniques
5
Microbiologist & Sterilisation Specialist Resume Examples & Samples
- Development & optimization of test strategies/ new technologies and adaption/ integration of new standards in compliance with regulatory requirements across sterilization/ microbiology
- Lead the development of solutions to complex technical problems related to product, processes and cleanrooms using problem solving techniques and methodologies
- Collaborate and partner with NPD functions to define, execute and deliver on NPD requirements ensuring robust and capable processes/ tests/ methods
- Drive functional excellence across sterilization and microbiology relating to cleanroom optimization and sterilization technologies including EtO, E-beam, Gamma and Steam Sterilization
- Represent Microbiology and Sterilization Services at a site level and externally on global teams/ technical forums
6
Microbiologist Resume Examples & Samples
- Assist other scientists through consultation on preservative selection based on prior knowledge
- Assists in the review, revision and instruction of training materials for new development staff members
- Participates in meetings with the international microbiology community and professional trade organizations
- Periodically review results, write reports and present project results to development teams
- Oversees a safe and orderly laboratory environment
- Solid understanding of GLP, USP, PCPC guidelines, AOAC Official Methods of Analysis, and ASTM methods
- Demonstrated ability to lead and work well with teams
- Experience with aseptic techniques, various media and culturing methods
7
Microbiologist Resume Examples & Samples
- Develops, implements, manages and tracks effectiveness of an integrated microbiological program, including systems, standards, procedures, measures and tools to assure that food safety, quality, sanitation and regulatory requirements are met for food products and operations
- Leads cross-functional project teams and/or sub-teams that require and develop microbial specifications and standards and procedure improvements
- Supports the management of potentially serious product incidents through science based food microbiology approach
- Analyzes quality metrics, customer feedback and workgroup input. Oversees investigation and resolution of microbial concerns from retail stores, field QA partners, and internal and external customers
- Represents quality assurance on enterprise-wide cross-functional teams as food microbiologist. Ensures company food products and business initiatives meet Food Safety and Regulatory requirements
- Collaborates cross functionally and globally to create alignment of microbiological programs across the company
- Recommends and oversees content updates to department or company resource manuals, standards manuals, training programs, and operational excellence tools. Oversees key stakeholder review of relevant operations communication vehicles
- Develops and delivers effective communications that provide partners at all levels with appropriate awareness and knowledge of microbiological standards, program updates and process changes
- Stays up to date and builds expertise in food microbiology best practices, public health regulations and industry best practices
- Auditing and leading continuous improvement of vendor quality assurance systems (10 years)
- Executing total quality management program for a food manufacturer (10 years)
- Ability to analyze complex data, draw conclusions and make recommendations
- Ability to articulate and sell quality assurance programs and continuous improvement goals to vendors
- Ability to assimilate new information quickly and react positively to new and challenging opportunities
- Ability to communicate effectively with supplier management team, internal customers and peers
- Ability to conduct scientific tests of food products
- Ability to make progress in spite of setbacks or lack of clarity
- Ability to manage and resolve conflicts
- Ability to operate effectively in a fast-changing environment
- Ability to solve vendor quality problems through data, processes and influencing skills
- Familiarity with food regulations
- Familiarity with quality documentation system
- Knowledge of food processing technology, ingredient functionality, microbiology and food safety
- Knowledge of quality assurance program methodologies and implementation within manufacturing environment
8
Associate Microbiologist, R&D Resume Examples & Samples
- Performs preservative efficacy testing on new developmental formulations, existing products requiring modification, and experimental projects
- Media preparation, culture maintenance, culture and media waste disposal
- Track and communicate data and results to Supervisor
- Maintain adequate levels of lab supplies, chemicals and medium
- Exceptional time management skills with the ability to organize and manage multiple priorities
- Set up, adjust, calibrate, clean, maintain, troubleshoot and document laboratory equipment including autoclave
- Documentation of testing results, equipment measurements, and media prep
- Ensure that Good Laboratory Practices are employed and followed
- Assist in writing, revising and editing standard operating procedures for microbiological testing
- Assist in the training of more junior team members
- Exhibit competence with computer systems available to R&D for formula management, requesting tests etc. (Microsoft Office)
- Conduct presentations to R&D on various topics as needed (i.e., raw material presentations and seminar recaps)
- Perform various lab duties including housekeeping and supply maintenance and ordering
- Other duties may be assigned or requested
- 2+ years experience in a laboratory environment
9
Associate Microbiologist, R&D Resume Examples & Samples
- Exceptional time managementskills with the ability to organize and manage multiple priorities
- Education: *
- Others: *
10
Senior QC Microbiologist Resume Examples & Samples
- Bachelor's degree in a science discipline
- Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling
- Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning
- Knowledge of related cGMP manufacturing regulatory/industry considerations, compliance issues and/or scientific discovery
11
Microbiologist Resume Examples & Samples
- Test and release samples requiring microbiological analysis
- Follow up and resolution of documentation issues
- Good knowledge of ISO and GMP requirements
- Good knowledge of waste management and environmental programs
- Current knowledge of all safety programs including JSAs and SHAPs
- Participate in audits as required (ISO, GMP, environmental)
- Equipment calibrations
- Ordering supplies
- Performs any other duties as directed
- Actively engaged in safety programs (MESURE, ISO, etc.)
12
QC Microbiologist Resume Examples & Samples
- Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release
- Rapid turnaround of samples to meet manufacturing needs
- Performing data review and approval
- Providing support and advice to manufacturing on QC related topics
- Initiating and leading investigations where required
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system
- Providing training to other analysts and to manufacturing personnel
- Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc
- Proactively identifies and implements lab process improvements
- Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc
- Supports Team leader on day to day testing operations
- Bioburden, Endotoxin, Sterility Testing and Microbial Identification using genetic methods
- LIMS, Electronic Lab notebooks, Empower, Trackwise etc,
- Third-level qualification (Minimum: Primary degree in a science discipline)
- A minimum of 2 years' experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products
13
Microbiologist Resume Examples & Samples
- To oversee/co-ordinate and execute where required use of all microbial services, review and develop procedures for all microbiology/sterility assurance activities
- Manage the environmental monitoring and utility monitoring program
- Manage applicable NC and CAPA to resolution and closure
- To co-ordinate and complete biological/biocompatibility testing and evaluations for product ranges as required
- To carry out internal auditing of all Environmental controlled areas, Lead ECA Re-certification activities including review and approval of associated documents
- To participate in audit of the sterilization subcontractors, contract laboratories and clean room clothing suppliers
- To implement the GMP training programme for environmental controlled areas and other appropriate staff
- To implement the microbial assurance aspects of the Quality System
- To participate in applicable Stryker Ireland projects as required
- Clear understanding of Sterilization and Biological Evaluation regulations for medical devices
- Clear understanding of cGMP for Environmental controlled rooms
- Knowledge of both the FDA and ISO regulations for medical devices
- Degree in Microbiology or equivalent
14
Microbiologist Resume Examples & Samples
- Lead the microbiology lab to ensure consistent delivery to customers
- Provide technical expertise for all aspects of testing and out of specification investigations
- Draft and review documentation -SOPs, protocols, training modules, investigations, reports and Trackwise documents
- Ability to perform key tasks such as: Environmental Monitoring, water sampling, bioburden, endotoxin, verifications, growth promotion and in-process testing
- Preform testing and ensure that testing schedule is adhered to and the results reported in a timely manner - escalation of any issues/OOS
- Conduct and document out-of-specification/out-of-trend result investigations
- Coach and develop individuals within the team
- Responsible for overall performance of the microbiology function in areas of technical delivery and inter-team and inter-department collaboration
- Collaboration with QC Leads and Associates to ensure the overall running of the QC Laboratory
- Ensure the team is compliant to GxP, safety and environmental standards
- Lead and implement initiatives that add value to QC and site operations
- Third Level Degree in Microbiology or equivalent scientific degree
- 5 years'+ Industry experience
- Minimum BSc in Microbiology or similar/equivalent
- Solid experience of environmental monitoring, clean utilities, microbial ID, plate reading, bioburden, endotoxin, verifications, growth promotion and in-process testing
- Demonstrated experience of developing and leading projects
- Sterile manufacturing and/or biotech experience is preferable
- Pharmaceutical drug/process development experience preferable
15
Microbiologist Resume Examples & Samples
- Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP
- Receiving and logging samples into the Micro Laboratory
- Performing Micro analysis of raw material, in-process, finished product and stability samples associated with development products according to specifications
- Performing micro analysis of water and environmental samples
- Monitoring Micro trends in a timely fashion
- Isolation and identification of organisms grown from test samples
- Liaising with external labs on any micro testing that requires off site testing
- Analysing validation samples according to validation protocols and investigational samples as directed
- Recording results in a timely and accurate fashion
- Ensuring the Right First Time KPI with respect to Analyst's documentation are achieved
- Reviewing co-workers/analyst documentation (i.e. Buddy System)
- Ensuring that all Quality Systems within the department are adhered to on a daily basis
- Ensuring correct labelling of laboratory reagents and samples
- Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
- Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance
- Training other laboratory staff as requested and appropriate
- A BSc Degree (life science)
- At least 3 years' experience working within a pharmaceutical cGLP environment (IMB and FDA approved)
- At least 2 years' experience working in a Microbiological testing role
16
Microbiologist Resume Examples & Samples
- Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards
- Monitoring of utilities including all grades of water, and where necessary, compressed air
- Co-ordination of samples for bioburden and endotoxin testing
- Trending and interpreting all associated data. Ordering consumables (media etc) and general stock for day-to-day running of laboratory
- Applying cGLP to all laboratory activities including stock control. Performing sampling for validations and re-qualifications as required
- Involved in NC and CAPA generation and resolution within the Microbiology group and across related business units
- Performs sterility release review
- Performs sterilisation validations and re-qualifications in line with relevant BS EN ISO standards
17
Microbiologist Resume Examples & Samples
- To support the microbial assurance aspects of the Quality System
- To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate
- To co-ordinate use of all microbial services
- To support the review and development of procedures for all microbial assurance activities
- To carry out regular internal auditing of all clean room facilities and other areas
- To implement the GMP training program for clean room and other appropriate staff
- To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required
- To support the release of sterile products
- To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate
- To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures
- To adhere to the Company's procedures as detailed in the SOP manual
- Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring
- To support specific projects as allocated by the International Sterility Assurance Manager
- All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform
- Degree level qualification in Microbiology or equivalent
- Minimum 3 years post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry
- Familiarity with microbiological aspects of GMP regarding sterile medical devices
- Experience of conducting GMP audits, internal and relevant external audits
- ISO 9001 Lead Assessor qualification
18
Process Microbiologist Resume Examples & Samples
- Actively supports Process microbiological investigations
- Maintain, re-evaluate and communicate key critical inputs to site
- Environmental monitoring programme
- Perform Risk Assessments for projects and business innovation initiatives from a microbiological perspective
- Drives strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene
- Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations
- Collaborates with Process Microbiologists across the network and the Microbiological Review Comittee
- Access global microbiology support resources as required
- Reviewing and approving of relevant QC TM's, SOP's and WI's
- Trouble shooting and support of manufacturing microbiological issues
- Anticipating and planning for future requirements in both Manufacturing and the QC area
- Ensuring activities are carried out in compliance with cGMP and company quality standards
- Maintains records of investigation in accordance with cGMP
- Participate in relevant internal and external QC related audits
- Deputises for the QC Manager or Team Leader as appropriate
- Support effective design and deployment of QC micro analyst training program
- Support technical troubleshooting of QC micro process related testing methodologies and techniques
- BSc in a scientific/technical discipline required
- A minimum of 5 years' experience within the biological and/or pharmaceutical industry
- Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment
19
Microbiologist Specialist Resume Examples & Samples
- Conduct training as part of the team responsible for delivery of the Microbiology Certification program and or/ Co-ordinate / conduct program for the LATAM region
- Provide appropriate consultations for microbiological inquiries and concerns. Help Divisions and bottlers on micro test protocols and troubleshooting. This may include support to new product introduction, particularly sensitive beverages
- Assess and authorize third party microbiology labs for testing, troubleshooting purpose; review and interpret testing reports and summarizing conclusions
- Implement micro methodologies and determine prices, ensuring the microbiology laboratory is suitably equipped, resourced and maintained to perform all necessary testing required by Company specifications and requirements
- Preparation of reagents, media and solutions for test usage. Includes operation of autoclave for media/equipment preparation and disinfection
- Conducting of microbiological tests using various methods such as direct plating, pour plate, membrane filtration and other potential rapid micro methods such as ATP / PCR if needed
- Evaluation of test results including understanding, identification and troubleshooting of contaminants identified as part of the testing process
- Determining sampling strategies and test methodologies for ingredients, intermediates and finished beverages. This may include strategies to measure/monitor sanitation practices, environmental conditions (air quality, water quality), and production validation (eg aseptic/ thermal processes)
- In consultation with R&D, providing guidance on micro sensitivity of ingredients, formula, process/plant facility; Updating knowledge regarding microbial risk in ingredients, process, and product; and propose appropriate countermeasure against it
- Comprehensive understanding of microbiological test methods and procedures. Includes aseptic technique, room equipment preparation, sanitation and disinfection, use of laminar flow, manifolds, autoclaves, incubators, plate counters etc
- Understanding of environmental monitoring techniques such as air sampling, swab tests
- Fundamental understanding of microbiological principles
- Understanding of processing techniques and conditions for sensitive beverages eg thermal, pasteurized, preservation
- Troubleshooting and IMCR
- Effective consultation and communication skills at all levels of the organization
- Ability to train /consult with others on microbiological principles and techniques
- Get the certification of Thermal Processing
20
Microbiologist Resume Examples & Samples
- At least 5 year’s experience in cosmetic microbiology laboratory
- Must be well versed in observing, monitoring and identifying microorganisms
- Maintaining of bacterial and fungal cultures
- Preparation of growth media
- Maintaining of media and equipment logs
- Experience in plate counting and sterile techniques
- Knowledge of preservative challenge test procedures
- Ordering of materials/equipment
- Analyzing/interpreting of data and writing reports
- Working knowledge of Microsoft Word, Excel and Power Point
21
Senior Microbiologist Resume Examples & Samples
- Using knowledge of microbiology and engineering to invent, design & develop new products incorporating 3M technologies
- Defining product specifications and build robust product designs that meet customer performance and usability requirements
- Defining verification & regulatory submission test plans, develop test methods, perform required testing, summarize and document test results
- Overseeing technical activities in global product registrations and with external partners
- Acting as technical lead on cross-functional product development projects
- Interacting with consumers to understand their needs and desires for our product platforms
- Training lab members on new and/or advanced techniques
- Contributing to intellectual property as applicable
- Master’s degree or higher in a science or engineering discipline from an accredited university
- Minimum of five (5) years combined research and development and/or laboratory environment experience
- Ph.D. in Microbiology, Biotechnology, Biomedical Engineering or a related discipline from an accredited university
- Microbiology experience with pathogenic microorganisms
- Organizational and project management skills– New Product Introduction (NPI), technical team leadership experience desired
- Experience in new product design & development with demonstrated success effectively contributing to cross-functional teams and commercializing new products
- Analytical abilities with demonstrated use of design of experiments and other statistical methods or tools
- Minimum one (1) year medical device and/or pharmaceutical industry experience
- Strong communications skills (written , verbal and presentation) with a focus on technical writing
- Passionate, self-motivated, inquisitive, imaginative, and detail-oriented
22
Process Microbiologist Resume Examples & Samples
- Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions
- Comply with EHS rules and procedures at all times
- Understand the potential EHS impact of their activities
- Attend and participate in EHS training as required
- Use PPE and safety equipment as required
- Report all incidents, accidents, and near miss events
- Report unsafe plant, equipment, acts, procedures or issues
- Make suggestions to improve health and safety in the workplace
- Actively participate in work area EHS teams
- Not turn a ‘blind eye’ to unsafe acts or situations
- Ability to operate as part of a team is critical
- Innovative
- Results and performance driven
- Adaptable and flexible
- Strategic Thinker
- Credo value of integrity
- To work as a strategic partner with all other departments
- A minimum of 5 years’ experience within the biological and/or pharmaceutical industry
- Possesses deatiled knowledge of routine and non-routine testing and sampling methods, techniques and related equipment
- Possess a detailed knowledge of the shop floor manufacturing process
- Possess a comprehensive knowledge of trending using statistical analysis
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
- Business Excellence and Problem Solving skills Qualifications e.g
23
Microbiologist Resume Examples & Samples
- In terms of micro laboratory services ensure all laboratory reagents, chemicals, test methods, equipment are acceptable for testing purposes
- Should be able to execute cleanliness drives and develop GMP standards
- Manage sourcing of Lab equipment, chemicals and micro consumables and ensure GLP standards
- Provide technical expertise on assigned areas related to microbiological, sanitation and food safety standard
- Sample and analyze ingredients, work in progress and finished product for microbiological compliance to specification
- Educates and trains colleagues in Food Safety to ensure compliance to Company Standards
- Carry out Microbiological reporting on FG on monthly basis
- Regarding GMP the person should Ensure FQPs and GMPs are in place covering Equipment & Building hygiene, Sanitation & Cleaning, housekeeping, Infestation & Pest management and Prevention of potential contaminants
- Conduct regular audits to assure compliance to the QPs/QCMS and Sanitation. Coordinate for Initiation and closure of corrective actions where required based on audit findings
- Actively participate in quality culture initiative and IL6S journey
- Support other team members in their area of work whenever a need arise
- Demonstrate experiences of practical application of the theory in Food science, microbiology and management system standards related discipline
24
Microbiologist Resume Examples & Samples
- A minimum of a Bachelor’s degree in Microbiology, Chemical Engineering or related Life Science is required. MS is preferred
- Process Excellence Certification is preferred (Green / Black Belt)
- ASQ Certification is preferred
- A minimum of three years’ relevant experience is required
- Experience in quality control in the medical product industry is preferred
- Three or more years’ experience in a GMP laboratory including but not limited to microbiological laboratory environment is preferred
- Excellent written and oral skills and the ability to organize and follow up on multiple priorities are required
- The ability to understand the application of regulatory requirements to the business, especially for controlled manufacturing environment to sterilization processes is required
- The ability to analyze and develop quality methods is required. Responsible for writing clear and concise protocols, study reports, and procedures
- Knowledge of changes in regulations and standards for sterilization and microbiology is required
- Bilingual in English/Spanish is preferred
- Moderate travel required- 25% -35%.Biology
25
Microbiologist Resume Examples & Samples
- Promote quality awareness across the company; contribute to the development of competence of quality professionals across the organization to develop the level of contribution of each subordinate and improve their performance
- Define and update the specific quality procedures, instruction and tools which are directly related to their area of concern to ensure high level of quality in using the designed system
- Support Nestlé Continuous Excellence program in the quest for zero defect, including root cause analysis after incidents (or near misses), DMAIC to continuously improve Nestle Quality according to its standards
- Support the delivery of training for their specific areas of concern to the required operating units to ensure the full comprehending of Nestle Guidelines and standards
- In their specific area of competence, assess that the Nestlé Quality Management System is in place, and is obtaining expected results in a given operating unit
26
Microbiologist Technical Leadership Program Resume Examples & Samples
- Plan and conduct experiments for the development of new products and processes under the direction of an experienced scientist or engineer
- Participate in a project during each rotation, following guidelines for new idea development or stage gate process
- Apply academic fundamentals to problem solving for product development
- Develop economic estimates and an understanding of the financial metrics for new products
- Analyze results and assist with decision-making for next steps
- May require supervision of one or more technicians
- Collaborate with other scientists and engineers in R&D, manufacturing, marketing, and customers for new product and process development
- Document and present results at project/team meetings
- Represent SEE at Infection Prevention conferences and other industry trade groups
- Represent SEE in Infection Prevention regulatory groups / agencies
- Maintain understanding of critical infection prevention trends in industry and academia and advise SEE accordingly
- Maintain relationships with academic and industry thought leaders in the area of infection prevention
- Contribute to Microbiology technology roadmap
- Must have completed a PhD degree before the intended start date
- Strong academic record (3.0 or higher GPA)
- Knowledgeable about general science and lab practices
- Basic understanding of research statistics with experience using statistical software
- Creative and a strong problem solver
- Excellent communication and presentation skills with experience presenting technical material to a non-technical audience
- Evidence of exceptional technical writing skills (e.g., peer reviewed publications)
- Knowledgeable of best practices for prevention of hospital acquired infections
- Experience in researching and developing chemical and/or non-chemical methods of microbial destruction highly desirable
- Ability to travel internationally, as needed
- Ability to relocate several times within the continent in order to complete various rotations that are part of the TLP
27
Microbiologist Resume Examples & Samples
- Product Performance schedule adherence
- Training and development
- Engagement and attendance
- Continuous improvement
- Role-model the Thermo Fisher 4I Values and use as a day-to-day guide in decision making
- Carry out Product Performance Testing in accordance with Oxoid test specifications and methods
- Plan, track and control the progress of products under test, and provide accurate availability dates to planning and customer services
- Release of raw material and product against defined specifications
- Ensure processes and procedures are carried out in accordance with the laboratory and company Quality Systems
- Ensure all test results are recorded within the SAP Quality Management module
- Alert team leader of potential problems/failures and assist with further investigation
- Build and maintain effective working relationships to ensure robust collaboration cross-functionally and with key stakeholders (key interfaces include Team Leader, PP Manager, warehouse, production, distribution, QA, customer services and planning) to ensure customer service level targets are met
- Liaise with team leader regarding prioritization of product and raw material testing
- Assist with coaching, training and qualification of personnel to acquire all skills necessary to performance product and material testing in a safe and quality manner
- Engage in PPI lean methodology including standard work and tier meetings. Use PPI processes to solve problems and improve departmental and business processes
- To fulfill the responsibilities of the position as defined in the Oxoid Health, Safety and Environmental policies and associated Codes of Practice. To actively promote Health and Safety awareness of all other employees
- HNC / Degree in Microbiology or Chemistry
- Decision Quality - Attention to detail and a systematic approach
- Problem Solving - Effective in technical and organisational troubleshooting to root cause
- Communicates openly creating collaborative relationships by developing strong work relationships, displaying integrity and building trust across functions
- Significant experience of product performance testing within a microbiology laboratory environment
- Drive for Results - Delivering consistent results by being action oriented, demonstrating organizational agility, planning effectively and setting priorities
28
Microbiologist Resume Examples & Samples
- Maintain accurate records and documentation; prepare accurate reports as needed
- Assist management in developing conclusions and actionable solutions
- Select and maintain microbiological supply inventories in a fiscally responsible manner
- Bachelor’s Degree in Biology or related field and 1-2 years related experience or training; or an equivalent
- Knowledge of HACCP principles
- Understanding of material risk from a food safety standpoint
- Knowledge of Statistical Process Control Principles
- Computer literate with a competency with Microsoft Office Applications, LIMS and SAP
- Knowledge of General Laboratory techniques, sample drawing procedures and test methods including sensory evaluation techniques
29
Principal Microbiologist Resume Examples & Samples
- Provide key input and direction to the Lamb Weston strategic food safety vision consistent with company management direction and FSMA requirements
- Champion a culture mindset of food safety first and foremost both horizontally and vertically across Lamb Weston
- Ensure the adoption of best food safety practices across the organization including pathogen environmental monitoring programs, food safety sampling and testing regimens, and leading-edge methods deployment
- Proactively participate in the Lamb Weston Corporate Food Safety Assessment process identifying gaps and developing plans to address the gaps
- Conduct portfolio risk assessments and recommend risk mitigation strategies and approaches
- Respond to food safety-related special situations and provides guidance and direction to the process
- Interact with key internal stakeholders such as Scientific and Regulatory Affairs, Quality & Innovation, Operations, Legal, and others on food safety-related issues, policies, and programs and procedures
- Collaborate with key stakeholders such as Procurement, Co-pack Quality and others to ensure Lamb Weston’s food safety standards are rigorously adhered to across the Global Supply Chain
- Lead the development, review and management of HARPC programs from a microbiological viewpoint
- Leads coordination of external laboratory services for analyses and data reporting
- Ensure all appropriate pre-requisite programs to HARPC including training, GMP’s, SSOP’s, and others are developed and functioning as part of Lamb Weston’s overall food safety system
- Consult and recommend to Process R&D as well as Engineering, food equipment design elements for improvement to microbiological safety and cleanability
- Provide manufacturing support, including advising Corporate Quality and plant personnel on
- Stand, sit, and/or walk for up to 8 hours a day
- Drive company or rental vehicle for up to 6 hours in a day, infrequently
- Occasionally will work in plant settings
- Use of lab equipment and tools
- Lift up to 25 lbs. occasionally and up to 50 lbs. infrequently
30
Senior Industrial Microbiologist Resume Examples & Samples
- Supervise a group of 3 microbiology and environmental personnel (Microbiologistt, Engineer and Technicians)
- Collaborate in a Chemical/Industrial R&D environment, lead projects, and serve as a key contact for microbiology needs globally
- Responsible for the microbiological quality of products and plants
- Support Research & Innovation microbiology projects in wide areas of applications including coatings, home and personal care, oil and gas, waste water treatment and environmental microbiology
- 20% of travel required
- Understand and follow key Solvay safety policies and procedures
- Demonstrate a commitment to safety
- Attend monthly safety training
- Know the location of first aid and emergency response equipment, chemicals, and chemical documentation
- Obtain equipment or process specific safety training as necessary according to the specific hazards
- PhD level with at least 5-10 years experience
- Expert in microbiology, with experience in the areas of industrial microbiology, product preservation and biocidal efficacy
- Strong interest in applied research at the boundaries of microbiology and chemistry
- Ability to oversee manufacturing plant good practices and hygiene activities
- Prior exposure to environmental activities preferred (e.g. biological waste water effluent treatment processes etc.)
- Demonstrated practical approach to problem-solving
- Ability to communicate effectively with both internal and external contacts, including major international customers
- Ability to travel in support of these activities (max. 20%)
- LI-TC2
31
Microbiologist Resume Examples & Samples
- Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program. Conduct the required testing and incubation of these samples in accordance with specifications
- Read and document results of appropriately incubated samples. Address all out of limits and positive test results by completing trending analysis (OOL investigation), retest procedures, gram staining, thermal death testing, microscopic analysis etc. Review and sign off completed paperwork prior to being sent to the Documentation Centre
- Perform daily solution bio burden testing, examining total count, coliform count and spore count in accordance with SOP. Ensure required documentation is completed, and required samples are accounted for. Conduct testing of raw materials upon request
- Conduct sterility testing for stability and import samples, initial and fractional qualification studies and requalification’s by open and closed method filtration and/or drop tests and macerations, in accordance with SOP requirements, completing all required documentation
- Collect and organize production samples and check for discrepancies against sterilized sample record. Maintain equipment and area for testing to ensure endotoxin free product and perform bacterial endotoxin testing per specification
- Perform solution Particulate Matter testing of finished goods and stability samples
- Perform required testing and complete documentation required for critical work request and protocols by prioritizing daily and weekly testing schedules to allow time for required tests
- Perform sterilizer qualifications to validate the sterilization process. Maintain records and analyze qualification data to insure quality products
- Drive continuous improvement of environmental controls by performing real time risk assessments in classified areas. Work on improvement projects and validations as assigned
- Maintain 6S within the lab areas assigned. Provide back-up coverage to the Sterility Assurance Department when needed
- Prepare, growth test and pH adjust a variety of media and buffer solutions, required for Sterility testing and Environmental monitoring. Rehydrate organisms and maintain stock cultures used for growth testing
- Maintain equipment inventories and order laboratory supplies as needed. Ensure equipment calibrations are performed in a timely manner. Prepare and sterilize laboratory equipment to ensure its availability for use, dispose of biohazard materials appropriately, and perform monthly preventive maintenance. Monitor incubator and refrigerator charts and thermometers daily
- B.Sc. Degree in Microbiology or related subject
- Minimum of 1-2 years Previous experience working in a Quality function
- Knowledge of Aseptic Technique and Microbiological Methods
- Previous experience in a manufacturing environment is an preferred
- Proficiency in MS Office Suite. Previous experience with Laboratory Information Management System (LIMS) is preferred
- Microbiological testing lab experience in the pharmaceutical industry. Knowledge of GMP, ISO standards, and regulatory/corporate requirements is an asset
- Effective analytical and problem solving skills and critical thinking abilities
- Communication skills, ability to work with all levels of the organization
- Ability to balance multiple priorities with excellent time management skills
- Detail oriented with the ability to work under pressure
- Uncompromising dedication to quality
- Ability to work off shift, holidays and plant shut downs on a rotating basis
- Coverage for production overtime Saturdays on a rotating basis is mandatory
- Must comply with Good Laboratory Practices
- When performing Sterilizer Quals: the work is conducted in extreme environmental conditions (temperature, humidity, wet, moving trucks, loud, hot pipes)
32
Microbiologist Resume Examples & Samples
- University Degree, B.Sc. designation
- Microbiology
- Experience in a lab or manufacturing environment
- Proficiency in Word & Excel
- Previous experience working in a Quality function
- Strong analytical and problem solving skills and critical thinking abilities
- Strong communication skills, ability to work with all levels of the organization
- Strong ability to balance multiple priorities with excellent time management skills
33
Microbiologist Resume Examples & Samples
- Execute testing related to the monitoring program of controlled environments of the Costa Rica site
- Contribute as matter expert on biocompatibility, sterilization and microbiology, assuring the product meets documented requirements and that processes are controlled
- Perform or participate in the validation of the Microbiology Lab�s new equipment
- Contribute to maintenance of the Sterilization Dosage audit program
- Coordinate the steps in order to perform Bio burden and LAL program tests on finished goods
- Execute testing related to the monitoring program of water systems of the Costa Rica site
- Perform the inspection of cultures received in the site
- Assure proper supply of reagents and materials required for lab operation
- Support tasks related to microbiology investigation systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system
- Support the decontamination of product contaminated with bio-infectious material, received as part of the customer complaint process
- Act as Quality Engineer for Facilities related matters
34
Senior Microbiologist Resume Examples & Samples
- Establish and maintain Microbiology labs in full cGMP-compliance
- Install lab equipment and performs qualification and validation activities of lab equipment following written protocols
- Provide guidance and support activities to run and validate necessary test methods or compendia methods in the lab and performs routine performs testing under cGMP
- Responsible for planning and generating method validation documentation and implement method in cGMP operations
- Provide guidance for procedure and method development (test method/assays) and ensure specific procedures are implemented to perform testing following routine activities
- Schedules and prioritize work for staff and develop training and analyst qualification programs to perform assays under cGMPs
- Reviews QA/QC documents to ensure completeness, accuracy, consistency and clarity and materials or final products have been manufactured, tested or inspected according to specification and cGMPs
35
Senior Microbiologist Resume Examples & Samples
- Be the on-site technical expert for sterilization validations, controlled environments, routine microbial monitoring requirements, product release testing, providing direction for manufacturing for modifications to controlled environments and facility auxiliaries and determine requirements for environmental testing. Works closely with other departments to ensure continued compliance to standards that govern manufacturing controlled environments
- Leads special projects as assigned to completion with minimal supervision, developing technically sound protocols and reports and participating in execution of validations/revalidation work
- Perform critical records documentation and review and participate in documentation preparation and assistance for regulatory audit review. Review and approve environmental monitoring data, escalates issues to management
- Performs root cause investigations and implement correction/corrective actions for controlled environment related excursions, with minimal supervision
- Owns internal lab procedures and performs regular reviews of current procedures and processes for improvements and updates as necessary to ensure continued compliance to standards
- Execute process validations/revalidations, in relation to setting up new laboratory equipment, assisting with protocols, data analysis, temperature studies, and reports, to contribute to goal achievements
- Responsible for managing various tasks within the lab environment, juggling different priorities, and meet communicated deadlines
- Will train, coach, and guide lower level employees on new and ongoing processes and procedures, assess work technique and provide feedback. May have the opportunity to lead a small team
- Knowledge of and experience with microbiology laboratory testing for medical device company is required. Knowledge of and experience working in a GLP compliant lab is desired
- Direct experience with sterilization validations and testing of medical devices, not limited to aseptic techniques for bioburden and sterility tests, culture maintenance, organism identification and characterization, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls
- Previous experience in supervising direct reports or teams required
- Proven expertise in MS Office Suite
- Proven experience in writing scientific reports and documents is desired
- Previous experience working with and understanding requirements for controlled manufacturing environments and knowledge of relevant ISO standards for controlled environments is strongly preferred
- Experience performing root cause investigations for laboratory test excursions and determining correction/corrective action is required
36
Microbiologist Resume Examples & Samples
- 1 Roles and Responsibilities
- Lab / Industry experience or handling equipment’s in sterile pharmaceuticals/ medical device production
- Should be ready to work in shift & should be able to manage the shift independently
- Perform standardized tests using general laboratory equipment. Performs routine care of designated test equipment and work area
- Recording of data & Operates computer to extract/input readily available information
- Evaluates test performance and reviews test data with supervisor
- Recording of data & prepare reports
- Equipment Qualification and handling
- Troubleshooting & management of shift operations
- Experience of quality tools
- Hands-on experience in validation of equipments/ processes/ methods
- Disinfectant qualification, preservative efficacy, cleaning validation, validation of testing methods for sterility, bacterial endotoxin test, hold time studies related to media, aseptic processing validation, sterilization, manufacturing, facility, utilities, processes, personnel/ environment monitoring and qualification
- Knowledge and working in a GMP environment
- Preparation of culture media and maintaining the stock, growth promotion test and documents pertaining to the media
- Microbiological quality control analysis of raw and finished materials and the completion and compilation of reports
- May supervise one or more Co-op/Operators
- Understanding of regulations applicable to devices, particularly standards
- Knowledge of material selection, International standards, and norms
- Knowledge of laboratory process
- Knowledge of ECN Process
- Design Verification and Validation
- Design and Risk Management documents
37
Associate Microbiologist Resume Examples & Samples
- Perform environmental monitoring within controlled environments, test water for microbiological contamination, and trend all associated data
- Conduct endotoxin evaluation of medical devices
- Participate in the execution of, development of and/or improvement of sterilization processes
- Review sterilization process and equipment validation/qualifications (IQ, OQ & PQ)
- Be a point of contact for suppliers for new process development, quality issues and process improvements for assigned projects
- Support product transfers
- Act with integrity and mentor others
38
Assistant Microbiologist Resume Examples & Samples
- Preparing samples and running microbiological tests (including tasks like preparing media, performing dilutions, plating, gram staining, reading results)
- Operating microbiological instrumentation like sterilizers, microscopes, BAX, & vidas
- Priority skills include teamwork, communication, adaptability, and support of continuous improvement
- Knowledge of GMP, GLP, and food production regulation
- Computer usage: LIMS, Office, Email
- Working knowledge of statistics, preparing reports, instrument maintenance, and validation process is desirable but can be trained
39
Plant Microbiologist Resume Examples & Samples
- Experience in and strong understanding of compliance and quality standards in a high care environment
- Excellent understanding of microbiological techniques & methods
- Very good interpersonal skills
40
Clinical Microbiologist Resume Examples & Samples
- Team member or lead on projects related to investigating failures in the production manufacturing environment as needed for QC lots, NCMR, NC and CAPA’s
- Team member or lead involved with implementing process improvements and help to implement process improvements and or corrective actions resulting from these failure investigations
- Reduce scrap and production and process related failures by providing input for building robustness in to the manufacturing process and product design
- Create and present reports on conducted experiments, failure investigations to upper management
- Team member to perform Risk Analysis or FMEA utilizing root cause analysis tools
- Utilize clinical microbiology expertise to evaluate potential manufacturing impacts on customer use
- The ideal candidate will have experience working in a hospital or reference microbiology lab . Experience must include performing culture work ups and reports including identification and susceptibility testing on actual patients (as opposed to food ,environmental, or research)
- An extensive knowledge and understanding of clinical microbiology
- Good working knowledge of basic chemistry and of bio-chemicals used to identify microorganisms
- This individual must possess the interpersonal skills to be able to work as a Team contributor, and individual contributor. In addition, the individual shall have the ability to function in a structured/organized manner, and the ability to follow through on given tasks
- Experience in and/ or knowledge of working in a manufacturing environment. In particular, a device regulated manufacturing facility
- Bachelor of Science degree in a microbiology, chemistry, medical technology, or biochemistry or related field is desired
- A minimum of 5 years of relevant clinical microbiology experience
- Strong organizational skills, Good laboratory techniques and operation of lab equipment
- Good problem solving ability, Good oral and written communication skills in English
- Good organizational skills and computer skills
41
Microbiologist Resume Examples & Samples
- Bachelor's Degree in Microbiology or related science
- Experience (3+ years) in Environmental Monitoring and/or Utilities Monitoring
- Experience with data trending and analysis
- Problem solving and decision making skills, with emphasis on data-based decisions and customer service
- Strong technical writing skills
- Expertise in current internal and applicable external standards for FUME, EM and Sterility Assurance
- CAPA Lead Investigator – Root Cause Analysis certification
42
Senior Level Microbiologist Resume Examples & Samples
- Use of risk-based approaches (i.e. HAACP, FMEA, etc.) to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination
- Identification and definition of acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis
- Execution of a risk-based approach to identify areas of highest risk in support of sampling location selection for Environmental Monitoring Performance Qualification and eventual identification of routine environmental monitoring sampling sites
- Lead or provide consultation for investigation of sterility assurance-related events and non-conformances
- Develop/maintain site programs for training and qualification of aseptic personnel
- Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections
- Influences corporate guidance associated with sterility assurance
- Develop sterility assurance strategies to be employed for new facilities/utilities or processes
- Provide oversight of the site TS/MS integrated sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, aseptic manipulation / intervention programs, sterility assurance risk assessment strategies, discard strategies, filter validation, and sanitization agent validation
- Develop and implement targeted process improvements, as well as strategic-level transformations, to site sterility assurance programs
- Serve as a sterility assurance subject matter expert and liaison for IPM across the global parenteral network helping to drive change, harmonization and replication
- Bachelors in Microbiology with a minimum of 10 years experience, or a Masters in Microbiology (or related scientific field) with 7 years minimum experience
- Knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. US FDA, EU, etc.)
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site goals
- Detailed knowledge and understanding of cGMPs and global compliance expectations for aseptic processing (e.g. US FDA, EU, etc.)
- Technical leadership skills
- Interpersonal skills including ability to effectively influence others
- Technical writing and presentation skills
- Ability to prioritize and attention to detail
43
Microbiologist Resume Examples & Samples
- Collect environmental and water samples at client facilities using sampling protocols and associated documents
- Perform Harmonized Microbial limits testing and Qualification
- Conduct Bacterial Endotoxin testing of water samples and product using Gel clot & kinetic Turbidimetric Methods
- Conduct Water Activity and Bioburden testing
- Routine environmental monitoring (viable and non-viable particulates)
- Water Analysis (Total Viable Count, absence of coliforms, Total Organic Carbon and Conductivity)
- Maintain Stock Culture for routine testing
- Sterility check incoming media and perform Growth Promotion testing
- Enter samples and data into Electronic Notebook and prepare required reports
- Trend and track data for annual reports
- Initiate and participate in investigations and CAPAs and ensure timely completion
- Pack and ship samples
- Order supplies and maintain laboratory and equipment
- Adhere to quality control and safety procedures, work in an organized manner, and comply with client site requirements
- At least one year GMP or manufacturing environment experience
- Experience with SAP ordering system and TrackWise investigation system
- Bachelor's degree in biology, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least 1 year of directly related experience
44
Microbiologist Resume Examples & Samples
- Calculate, evaluate, review, and properly communicate data verbally and in written format
- Perform aseptic microbiological testing of samples including Bioburden, LAL, Conductivity, and Endotoxin on raw materials, manufacturing components, and lab supplies
- Record and document data according to regulatory requirements
- Aseptically collect and submit environmental monitoring (EM) samples at client facility using sampling protocols and associated documents
- Set up and validate new analytical procedures or related processes used by the department; perform benchwork for validation studies
- Calibrate and clean equipment as necessary
- Ability to access and use computer programming including PC software
- Read, understand, and follow the principles of methods and procedures used in assigned work
- Prepare documents (including, but not limited to analytical procedures, standard operating procedures, explanations of data, investigations, and protocols) in a written format
- Work overtime and/or adjust working hours when necessary to meet client requirements
- Train personnel to perform laboratory operations
- Operate and maintain sophisticated instrumentation (isolators, sampling equipment, environmental monitoring equipment, identification equipment, particulate equipment)
- Troubleshoot and repair laboratory equipment under direct supervision and assist in investigations
- Review testing using manual or computerized data systems while complying with all compendial and regulatory requirements
- Work on special projects with general supervision and draft reports with assistance from others
- Bachelor's degree in microbiology, life sciences, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least one year related laboratory experience (microbiology and environmental monitoring in a GMP facility preferred)
45
Principal Microbiologist Resume Examples & Samples
- Duties may be executed in a CONUS or OCONUS laboratory and include performing analyses of samples that have been collected
- Create and design new methods to support expansion of laboratory capabilities and improve/solve existing method deficiencies
- Develop Standard Operating Procedures (SOPs)
- Expertise in emerging technologies for biological threat agent analysis
- Design, Lead, and oversee research and development and method development efforts
- Develop experimental designs and test plans
- Oversee the execution of test plans
- Train on molecular biology and/or microbiology topics including sample collection/analysis/ threat-agent production
- Expertise in current and emerging bioanalytical tools and techniques
- Analyze and interpret data
- A Ph.D. in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) coupled with 5 years directly relatable experience
- 10 years of experience working in the Intelligence Community (IC) environment
- Must be able to successfully pass a skills assessment
- Extensive experience working in and/or leading operations, research and development, and/or method development in a microbiology, biology, clinical, genetics, or forensic laboratory
- Eligible for both US Tourist Passport and US Official Passport
46
Associate Microbiologist Resume Examples & Samples
- Understanding of basic biology and microbiology concepts
- Follow methods to support expansion of laboratory capabilities
- Follow and properly use Standard Operating Procedures (SOPs)
- Review, evaluate, and analyze data from samples and provide database entry support
- Experience and/or knowledge of emerging technologies for bio threat agent analysis
- Provide technical support involving research and development and method development efforts (including laboratory work as needed)
- Assist in the execution of test plans
- Assist in provide training on molecular biology and/or microbiology topics including sample collection/analysis/threat-agent production
- Collect potential microbial or bio threat DNA samples from materials using approved procedures designed to minimize the possibility of sample contamination
- All samples shall be properly packaged, marked and stored in preparation for extraction
- Familiarity or use of the following instruments and equipment
- A Bachelor’s degree in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) OR five (5) years directly relatable experience
- One (1) year of experience working in the Intelligence Community (IC) environment
- Currently have an active DoD Secret security clearance
- U.S. citizenship
- Previous experience working in a microbiology, biology, clinical, genetics, or forensic laboratory performing analysis of biological samples, including sequencing
- Deployment experience in an analytical/operational environment
47
Senior Microbiologist Resume Examples & Samples
- Develop new methods to support expansion of laboratory capabilities and improve/solve existing method deficiencies
- Developing Standard Operating Procedures (SOPs)
- Experience and/or knowledge of emerging technologies for biological threat agent analysis
- Lead and support research and development and method development efforts (including laboratory work as needed)
- Develop or assist in developing experimental designs and test plans
- Provide training on molecular biology and/or microbiology topics including sample collection/analysis/threat-agent production to Junior staff
- Identify and research new and emerging technologies for biological threat agent analysis, and provide recommendations on platforms or instrumentation regarding their suitability for specific needs
- Understanding and knowledge of current and emerging bioanalytical tools and techniques
- Collect potential microbial or biological threat DNA samples from materials using approved procedures designed to minimize the possibility of sample contamination
- Generate DNA sequences from biological materials
- Experience and expertise in using, maintaining, and troubleshooting the following types of equipment and instrumentation
- A Bachelor’s degree in science (e.g., biology, biochemistry, microbiology, clinical laboratory sciences, genetics, microbial ecology, microbial genomics, molecular biology, or forensics) coupled with 10 years directly relatable experience OR a Master’s degree
- 5 years of experience working in the Intelligence Community (IC) environment
- Must be able to successfully pass all medical requirements for deployment, as needed
- Experience working in a microbiology, biology, clinical, genetics, or forensic laboratory performing analysis of biological samples, including sequencing
48
Microbiologist Resume Examples & Samples
- Performs QC Lab activities by following relevant present SOPs
- Prepares and revises QC relevant SOPs, associated training materials
- Prepares reagents that are to be used for analysis
- Records analytical data in notebooks, logbooks and Specification and Quality Assurance Report and laboratory analysis forms accurately. Records results in a trending monitor perspective
- Performs calibration and preventive maintenance activities of Lab equipments
- Analyses products, raw materials, packaging materials and stability samples according to laid down procedures in Impax testing methods. Conduct analysis for microbial limits, assay, microbial identification, environmental monitoring, etc
- Calibrates equipment as required, in accordance with set methods and procedures
- Reports malfunctioning equipment to Laboratory Supervisors or deputies for repair
- Alerts Laboratory Supervisors or deputies verbally in the event of any result not meeting Impax specification or of any questionable results generated
- Ensures adequate stocking of Laboratory reagents and consumables, through monitoring re-order levels and timely notification to Laboratory Supervisors or deputies
- Records expiry dates of analytical reagents developed in-house by noting the expiry date on container or document
- Handles and disposes dangerous materials, such as pathogen, arsenic, cyanide, and concentrated acids, in accordance with standard safety practices
- Records regulated toxic controlled chemicals usage and disposition in accordance with standard predetermined procedures
- Maintains neatness of laboratory that following the concept of 6S – Sort, Set in order, Shine, Standardize, Sustain, Safety
- Supports investigative testing and investigation activities
- Perform in a continuous improvement attitude to meet the predetermined KPI
- Follows the training program schedule to complete the directed training courses
- Performs certification activities in accordance with regulatory and industry requirements like granted license for operating autoclave
- Completes delegated tasks by the agreed completion date and treat as commitment
- Attends weekly laboratory meetings or delegated meetings
- Other duties as assigned by the supervisors or company
- B.S. or higher degree in science or Pharmaceutical Science (pharmaceutical experience preferred). Major in microbiology education is preferred
- Microbial Laboratory operation experience is required
- Computer skill such as: Word, Excel, etc
- Database knowledge is a plus
- English reading and understanding is required. Fluent speaking and good writing in English is a plus
49
Microbiologist Resume Examples & Samples
- Performing environmental monitoring in cleanrooms (aseptic manufacturing)
- Basic Knowledge of microbiological monitoring techniques and microbiological test procedures
- MS Office literacy
- Medium or Higher education degree with the basics of microbiology
- Communication skills, assertiveness
- Teamwork skills
- Experience of working in a similar position will be an advantage
- A intermediate knowledge of English (speaking, comprehending, reading and writing) is preferred
50
Microbiologist Resume Examples & Samples
- Provide expertise for the Microbiology Laboratory and Aseptic Manufacturing Environmental Monitoring Processes
- Facilitate problem solving, investigations, and process improvements to successful completion for the aseptic processing area
- Provide microbiology expertise to resolving aseptic manufacturing problems, both for QCM and Aseptic production
- Other work assigned by line manager
- You have MS/Ph.D in Microbiology related
- You have good English skill (both oral and written) and skilled in MS office operation
- Minimum 7 years Microbiology pharmaceutical experience working in a GMP-regulated environment or Minimum 7 years aseptic manufacturing experience
- Previous experience with pharmacopoeia methods for water/product analysis such as TFS/TVC/LAL/Microbiology ID tests, environmental monitoring analysis (CP/USP/Ph.Eur)
- Experience to give microbiology insight to bacteria and other related areas
- Previous experience leading or managing projects
- Ability to coordinate continuous improvement activities related to aseptic conduct and technique, Microbiology testing, environmental monitoring and clean room classification
- Strong communication skills (verbal and written) and the ability to author scientific and technical reports
51
Microbiologist Resume Examples & Samples
- Performs Microbiological testing on Raw Material, Finished Products and Stability samples - such as Sterility Testing, Bacterial Endotoxin testing, Particulate Matter testing, Bioburden test, Antibiotic assays, Microbial Limits test, Preservative Effectiveness test, Container Closure Integrity test and Bacterial Retention tests. 70
- Support validation functions. Performs enumeration of Biological Indicators. Maintains user logs and BI history data. 15
- Maintains environmental isolates and identifies environmental isolates. Performs evaluation of thermal resistance of spore formers. 10
- Performs recertification of clean rooms and plant systems. 5
- Reviews equipment charts for specification compliance
- Supports media preparation by performing Growth Promotion
- Follows Teva Safety, Health, and Environmental policies and procedures
- Other duties, as assigned, or as business needs require
52
Senior Microbiologist Resume Examples & Samples
- Conduct micro analysis
- Help manage workflow of routine daily operations
- Ensure operations adhere to quality procedures and standard methods
- Provide technical assistance to external and internal customers regarding microbiological enquiries
- Answer customer enquiries
- Trouble shooting of analytical and field applications
- Bachelor degree in microbiology or related fields
- Minimum 5-6 years’ experience in microbiological testing
- Good organizational skill
- In depth understanding of ISO17025
- A good team player
53
Microbiologist Resume Examples & Samples
- Ability to perform key routine tasks i.e. environmental monitoring, sterility testing, bioburden testing, growth promotion quality (GPQ) testing etc
- Timely completion of documentations and data entries for routine tests to ensure laboratory testing cycle time is met
- Develop protocols and new procedures to revise existing procedures to comply with requirements
- Execute validation studies for laboratory processes, qualification for instruments, where applicable
- Support laboratory investigations for deviations/non-conformances, such as out of specification (OOS) results for routine samples
- Support development and improvement of laboratory processes and systems
- Ensure compliance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Follow laboratory safety rules, regulations and standard operation procedures required for the task assigned
54
Microbiologist Resume Examples & Samples
- Microbiological analysis according approved laboratory method
- Release checked raw materials in time as same as final product
- CAPA in case of unacceptable microbiological results
- Ensure microbiological analysis for another MDLZ plant
- Ensure microbiological analysis in case of special situation
- Keep MDLZ procedures – focus on quality safety and environmental rules
- Calibrations and validation of laboratory equipment
- Must be fluent in English - both written and spoken
- University degree in Food, Veterinary, Medical or Chemical field
- Strong PC systems skills (Word, Excel, PowerPoint)
- Knowledge of legislation for the food industry is required
55
Microbiologist Resume Examples & Samples
- Conduct routine environmental and systems monitoring of manufacturing and laboratory areas
- Conduct general laboratory experimentation in compliance with the instructions provided in approved SOP’s to determine appropriate action
- Follow policies and assists in the development of new procedures and/or documents
- Maintain records of experiments performed and results obtained including appropriate calculations
- Assist in the interpretation of data as require and conduct accurate and precise experimentation and complete documentation of results
- Assist in the preparation of data for presentations
- Maintain a level of technical knowledge and understanding in the assigned areas of responsibility consistent with the scientific requirements of the company
- 0-2 years of relevant experience in pharmaceutical microbiology
- BS degree in Microbiology or other life science from an accredited college or university or equivalent experience
- Proficient in the use of computer word processing, spreadsheet management, and data graphics programs
- Ability to qualify Class 100 gowning and maintain a qualified status
- Good oral, written, and interpersonal English communication skills
- Ability to read and accurately follow the instructions of standard operating procedures
- Ability to effectively utilize scientific information resources
56
Microbiologist Resume Examples & Samples
- Work schedule: Mon-Fri 8-4:30
- FSIS is a public health agency; you may be required to work occasional weekends or holidays
- Independently plans and carries out assigned microbial analyses on a variety of samples of meat, poultry, and egg products, including the very difficult, complex, or unusual samples and analytical requests submitted to the laboratory
- Performs the full range of microbial examinations of meat and poultry products and their ingredients to determine the presence, numbers and species of bacteria with particular emphasis on salmonella, listeria, staphylococcus, clostridium, E. coli 0157:H7, and other species important in food intoxication, food inspection, and sanitary microbiology
- Prepares and maintains reagents, and control cultures necessary to perform assigned analyses. Performs all necessary quality control and quality assurance procedures of instruments, equipment and reagents
- Performs quality testing of media and reagents and performs lot acceptance on commercially acquired test kits and reagents. Maintains quality assurance records in such a manner that they serve as documentation for ISO Guide 17025, the Microbiological Laboratory Guidebook, and the Quality Assurance Plan of the laboratory
- Interprets and evaluates the results of the microbial analyses and compares the results to pertinent agency regulations to determine whether the sample meets regulatory standards
- Partakes in an on-going assessment of established analyses and make recommendations to higher authority when sufficient evidence supports changes to standard operating procedures or an established methodology
- Develops and writes laboratory and section work instructions, spreadsheets and forms
- Experience in using standard quality systems; AND
- Experience in developing and modifying analytical methods; AND
- Experience planning and conducting microbiological analyses to solve complex scientific and technical problems; AND
- Experience in interpreting findings
- Experience using standard quality systems; AND
- Experience developing and modifying analytical methods; AND
- Experience interpreting findings; AND
- Experience in writing protocols and laboratory communications
- Experience writing complex protocols, laboratory communications, and scientific publications
- May be subject to satisfactory completion of one year probationary or trial period
- Have your salary sent to a financial institution of your choice by Direct Deposit/Electronic Funds Transfer
- If you are newly hired, the documentation you present for purposes of completing the Department Homeland Security (DHS) Form I-9 on your entry-on-duty date will be verified through the DHS "E-VERIFY" system. Federal law requires the use of E-VERIFY to confirm the employment eligibility of all new hires. Under this system, the new hire is required to resolve any identified discrepancies as a condition of continued employment
- If you are selected, you may need to complete a Declaration for Federal Employment (OF-306) prior to being appointed to determine suitability for Federal employment and to authorize a background investigation. False statements or responses on a resume or application can jeopardize employment and may be grounds for disciplinary action, including removal from Federal service
- A background investigation is a requirement for this position. Appointment will be subject to the applicant's successful completion of a background investigation and favorable adjudication. Failure to successfully meet these requirements could lead to adverse action proceedings including possible termination
57
Senior Microbiologist Resume Examples & Samples
- Develop microbiological, toxicology and biocompatibility test methods and protocols
- Develop strategies for the application of ISO, FDA and other applicable guidelines to the biological analysis of medical products
- Conduct, interpret and communicate results of analysis
- Author protocols and reports
- Management of lab equipment and supplies inventory
- Assess impact of testing on medical device products and develop system to minimize negative impacts
- Manage and report all sterilization validations compliance with assigned responsibilities
- Actively support and advise on new product development activities
- Lead and participate in the development and improvement of processes for existing and new products
- Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ)
- Act as mentor to technicians
- Interact with outside vendors, manufacturing sites and other sources on sterilization validation requirements
58
Microbiologist Resume Examples & Samples
- Daily/Weekly/Monthly Routine tasks and maintenance of equipment to include but not exclusively; switching on VLF, Class II cabinet, Boiling water bath, checking lab fridge and production fridge for in-process samples and calibration of balances in Class II and VLF cabinets
- Media preparation (pH testing of media, autoclave waste & sterilisation of equipment)
- Collecting delivers from goods-in
- Quality control testing of media
- Maintenance of stock culture isolates
- Producing spreadsheet for ordering and placing orders
- Inventory of stock and stock rotation
- Stock up of lab consumables
- Preparation of logbooks
- Taking action in response to Eurotherm excursions
- Performing water and environmental monitoring testing (e.g contact plates, SAS air samples, drain swabs, compressed air samples, Gland loop samples, settle plates, rinse water samples) and arranging sample times with production
- Reading and recording results for water and environmental monitoring
- Responding to OOS/ATR in accordance with SOP47/166 and other relevant SOP’s
- Finished product and raw materials testing
- Assist in gathering information for investigations conducted by senior grades
- Receiving, adding batches and reporting results on LIMS
- Updating the batch tracker for Microbiology testing dates
- Writing MSRs for stability and development products
- Auditing – surveillance audits
- Identification of microorganisms – Sub-culturing, primary identification, Secondary identification using API
- Trending of data, printing graphs for transcription checking
- Assisting in writing of validation protocols and technical reports with guidance from line management
- Assisting in the review and evaluation of protocols to ensure successful execution in a timely manner
- Assisting where required in the evaluation and reporting of out of specification or atypical results
- Owning and writing Trackwise PR’s and reports
- Recording and documentation of experimental data and assisting in determining the conclusions
- QUMAS originator
- Execution of validation work (equipment & product)
- Demonstrable experience as a Microbiologist within Pharmaceutical or highly regulated industry
- Degree (or equivalent) in Microbiology
- Strong communicator both written and spoken
59
Senior Microbiologist Resume Examples & Samples
- Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws
- Collects purified water samples from the various USP Purified Water Loops used to manufacture or test drug products
- Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components
- Prepares samples for shipment to outside contract laboratory for microbiological testing
- Performs microbiological testing on water, bulk pharmaceutical chemicals and drug products
- Collects environmental samples for microbiological analysis
- May coordinate and perform the microbiological laboratory activities, equipment calibrations and certification
- May coordinate microbiological test with sub-contracted laboratories. Assists supervision in expediting results
- Samples final products for the micro count test. Conduct aseptic samplings for evaluation of compress air and cleaning processes
- Performs related support activities and duties as assigned
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
- Sampling methods and quality control systems
- Mathematics including basic statistics
- Basic Microbiology or related sciences
- Operating a personal computer
- Accurately performing routine testing procedures, as scheduled
- Reading, writing and speaking English
- 4-Year Degree with 5+ years of experience performing microbiological testing on water, bulk pharmaceutical chemicals and drug products
60
Microbiologist Resume Examples & Samples
- The position is responsible for housekeeping and will serve as the plant coordinator. The responsibility requires: monthly audits with department supervisors; written audit reports to the department supervisors
- Bioburden reduction. Perform microbial analysis to quantify and on occasion specialty latex device bioburden. Propose, evaluate, and implement corrective actions
- Perform air/water/surface sampling and plate counts
- Make/prepare Bio Media
- Manage facility Process Water System
- General Microbiology – Challenge the present microbiological procedures (i.e.; test methods, test frequencies, data analysis), sanitation procedure improvements, housekeeping training, sanitizing challenges, etc
- Bachelor’s degree in Microbiology, Biology, or related field
- Minimum of 5 years experience
61
Microbiologist Resume Examples & Samples
- Analyzes ingredients, products and related samples for populations of spoilage and pathogenic microorganisms using various techniques including VIDAS, PCR and other genetic based methods
- Plans and conducts applied research projects such as shelf life studies, challenge studies and other special projects on request
- Assists with troubleshooting microbiological issues related to food manufacturing
- Guides and trains laboratory technicians and associate microbiologists
- Stays current with pertinent scientific literature, performs literature searches
- Orders or assists in ordering lab supplies
- Serves as leader and go-to person in their work area
- Interact and guide/train plant laboratory personnel
62
Microbiologist Resume Examples & Samples
- Accepts and reports automated susceptibility results as substantiated through quality control and sensitivity patterns of specific isolates
- Valid California clinical laboratory scientist license
- Ability to effectively lead, mentor and/or develop other staff
63
Microbiologist Resume Examples & Samples
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
- Validates microbiology test methods
- Review data generated by other Microbiologists
- Trains Microbiologist I on microbiology test methods
- Conduct microbial identifications
- General microbiological laboratory techniques and procedures
- Sampling methods, automated identification and quality control systems
- Classical microbiology techniques (i.e. gram staining, pour and streak plating, culture maintenance, aseptic techniques)
- Microscope, autoclave, and laminar flow hood usage
- Mathematics and statistics
- Microbiology or related sciences
- Sample preparation techniques
- Computer applications and programs
- Reading, understanding and compliance with Company policies and procedures, including safety rules and regulations
64
Senior Microbiologist Resume Examples & Samples
- Use standard microbiological techniques to maintain, enumerate, isolate, and/or identify cultures of microorganisms
- Conduct microbiological efficacy tests following standard operating procedures and published AOAC and ASTM test methods
- Maintain cell culture and virus stocks
- Assist in solving customer-related microbiological issues and contribute to the development of differentiated technology, products, processes, and/or systems
- Perform new technology screens and participate in re-formulation testing on an as-needed basis
- Demonstrate initiative and ability to work independently, as well as in a team environment
- Collect and analyze data, summarize findings in oral or written reports, and make recommendations to project leads to drive formulation decisions
- Use critical thinking skills used to interpret and respond to customer needs
- Utilize strong oral and written communication / presentation skills
- Embrace Ecolab’s safety culture
- Bachelor’s degree in Microbiology, Biology or Food Science
- 2+ years of lab-based R&D or industrial experience in microbiology, food safety, pharmaceutical, or biocide industries
- Experience in AOAC and ASTM antimicrobial test method execution
- Experience troubleshooting microbiology test methods
- Experience working in a customer-driven laboratory setting
- Experience with molecular biology
- Ability to manage multiple projects and meet strict deadlines
65
Analyst, Microbiologist Resume Examples & Samples
- Bachelor's degree focused in Microbiology, Biological Sciences or related field
- 0 - 1 or more years of relevant scientific experience working in an analytical laboratory
- Experience working in an FDA regulated environment
- Prior experience with preparing biological samples, titers, and biological resistance testing
- Understanding of sterilization, gram stain or microbial ID
- Familiarity with GMP's; as well as being able to handle multiple, competing priorities
- Ability to work with minimal supervision to creatively accomplish technical tasks
- It is required that the candidate be flexible on work schedule(s), to include weekends
- Shift times include 6am-3pm or 10am-7pm with work week Tuesday - Saturday and/or Sunday- Thursday
- Experience with independent projects
- Experience with bacterial spores, sterilization or medical device manufacturing
- Having strong technical writing skills
66
Sterilization Microbiologist Resume Examples & Samples
- Collaborate with Quality, Manufacturing, Laboratory and Regulatory functions to ensure sterile label claim, key business projects and timelines are met and supported
- Lead and conduct sterilization validations for both ethylene oxide and radiation sterilization modalities for new products and to improve performance for existing products
- Conduct annual ethylene oxide re-qualifications of existing sterilization cycles
- Conduct quarterly dose audits for irradiated products
- Evaluate impact of product changes on existing sterilization validations
- Assess sterilization and manufacturing non-conformances for impact on product sterility
- Conduct product bioburden assessments initially and monitor over time
- Assists Regulatory functions in the preparation and response to regulatory submissions
- Provides sterility assurance knowledge during compliance and regulatory audits
- Bachelor's degree or higher in a Science or Engineering discipline from an accredited institution
- Minimum of one (1) year of combined work experience in a Quality, Technical, Manufacturing, and/or Laboratory environment
- Bachelor’s degree or higher in Microbiology, Biology, Chemistry, Chemical Engineering, Bio-Medical Engineering or related discipline from an accredited institution
- Minimum of three (3) years of experience in Sterility Assurance or Microbiology related field
- Experience with and complete understanding of International Organization for Standardization (ISO) 11135, ISO 11137, ISO 10993-7 and 11737 international sterilization and microbiological standards for medical devices
- Experience with Ethylene Oxide (EO) and/or Gamma Irradiation sterilization technologies
- Experience with microbiological sterility testing and bioburden test methodologies
- Experience working with quality systems applied to health care industry: ISO 13485 and Food and Drug Administration (FDA) Quality Systems Regulations (QSR) for medical devices, Current Good Manufacturing Practices (cGMP) for drug products
- Strong demonstrated ability to lead teams, identify opportunities for improvement, and drive change
- Ability to critically review and evaluate data and make conclusions/recommendations based on the data
- Excellent communication skills (oral, written and presentation)
- Self-driven with excellent organization and leadership skills
67
Team Leader Microbiologist Resume Examples & Samples
- Bachelor's of Science Degree in Biology or Microbiology
- 2-5 years experience as a Microbiologist in a manufacturing plant
- 2-5 years experience as a supervisor
- Proven ability to provide coaching and feedback and to influence others
- Excellent interpersonal, verbal, and written communication skills
- Capability to manage work objectives for self and direct reports
- Ability to prioritize multiple activities This position requires a candidate to be willing to complete a leadership selection process or have previous leadership experience
68
Senior Microbiologist Resume Examples & Samples
- B.S. in Microbiology/Food Microbiology from an accredited institution with a min 8 yrs of food industry exp or M.S./Ph.D. in Microbiology or Food Microbiology with up to 6 yrs of food industry exp
- Strong foundational knowledge of food microbiology (spoilage organisms, pathogens, indicator microorganisms). Exp with low moisture foods highly desirable
- Solid hands-on laboratory microbiology skills (bacteria, including major foodborne). Experience with microbiological rapid method validation, verification, and matrix extension. Experience with design of microbiological challenge and shelf-life studies. Lab supervisory experience highly desirable
- Solid understanding of FSMA, thermal processing, HACCP, food safety and sanitation principles
- Ability to utilize in-depth knowledge, problem-solving skills and an awareness of PepsiCo priorities to achieve stated results and to provide microbiological insights and problem resolution paths
- Must demonstrate initiative, commitment, resourcefulness and a passion for supporting Innovation and improving the Quality of PepsiCo's brands. Proven research project design, application and project mgmt skills
- Strong data interpretation skills. Demonstrated ability to distill data and/or test results into business-focused technical recommendations
- Functional computer software skills (Microsoft® Word, Excel, PowerPoint, Outlook). Travel within US is required estimated at 15-20
69
Microbiologist Resume Examples & Samples
- BA in Microbiology/Analytical Chemistry and/or Environmental Chemistry
- Demonstrated knowledge of microbiology laboratory techniques, equipment, terminology and procedures, including mathematical calculations used in microbiology analyses
- Demonstrated knowledge of standard laboratory safety practices
- Demonstrated knowledge of principles and procedures of laboratory record keeping
- Mastery of general microbiology including
70
Microbiologist Resume Examples & Samples
- Experience working in a laboratory using traditional and/or molecular microbiological methods
- Working to ISO9001, ISO17025, GLP or similar
- Working to strict delivery deadlines
- General microbiology and/or molecular skills/knowledge
- Use of Microsoft Office
- Aseptic technique
- Ability to follow standard operating procedures and Health and Safety documents and verbal instructions efficiently
71
Senior Microbiologist Resume Examples & Samples
- Analysis of finished products and Raw materials, and assurance of suppliers' compliance with FRONERI standards
- Verification of all the food safety programs as required in FRONERI
- Ensuring all Category products meet design , food safety and quality policy requirements defined
- 3 - 4 years experience in an FMCG is a must
- Bachelor's of Science or Bachelors' of Agriculture graduate
- Very good communication skills
- ISO 22000 Certification
72
Microbiologist Resume Examples & Samples
- Ensure that all aspects of laboratory/micro testing is in accordance with laid down procedures and SOP's
- Provide and ensure a high level of service, both to internal and external customers
- Perform failure investigations and support the site with microbiological evaluations/testing
- Ensure accurate compilation of reports in time and that all relevant information is noted complete and accounted for
- Ensure that laboratory equipment is operating efficiently and that consumables are ordered timeously
- Ensure a high level of service on special projects which could include calibrations, standardisations, system suitability, analytical methods, SOP updates
- Assist in and perform training of associates wrt microbiological topics
- Represent the micro lab during internal and external inspections/audits
- Report any stability issues and deviations immediately to the superior/ QC Manager when testing any samples
- Maintain skills and competencies by participating in all company endorsed 12. Adhere to all company health and safety rules at all times
73
Associate Microbiologist Resume Examples & Samples
- Assists in maintaining requirements for ISO 17025. (International Organization for Standardization, global quality standard for testing and calibration laboratories)
- Assists in developing, writing and updating, laboratory SOP’s and approved procedures
- Participates in the API proficiency program
- Analyzes ingredients, products, and related samples for spoilage and pathogenic microorganisms
- Plans and conducts applied research projects such as shelf life studies, challenge studies and other special projects upon request with assistance
- Involved with analysis of new methods for detecting, enumerating and identifying microorganisms of concern
- Perform other assorted duties related to quality assurance, research, and laboratory operations as assigned
- Guides and helps laboratory technicians
- Maintains accurate and detailed laboratory data and notebooks
- Maintains and calibrates instruments and equipment as well as a clean laboratory environment
- BS Degree with major studies in Biology, Microbiology, Food Science or Biochemistry required
- Minimum of 1 year related laboratory experience
- Ability to work with limited supervision, and work with others as a team
- Basic knowledge of food safety, food development processes, and aseptic technique
- Good interpersonal and relationship skills
- Ability to follow technical procedures
- Ability to collect and analyze data, draw conclusions based on facts, and write concise reports
- Weekend/overtime work required
- Mininum travel to plants required
74
Microbiologist Resume Examples & Samples
- Responsible for the Go Live
- Responsible for Raw and Pack Materials
- Monitoring and Analyzing the Raw and Pack Materials following the Inspection Plan and the QMS for physical, chemical and Microbiological analysis
- Suppliers auditing and development
- Ensuring the adherence to quality standards and guidelines for finished and raw materials
- Bachelor's of Pharmacy or Bachelor's of Food Science Graduate
- 1 - 3 years experience in an FMCG
- ISO 17025 accreditation is a plus
- Advanced communication skills
75
Associate Microbiologist Resume Examples & Samples
- Under the supervision of other scientists, works on problems of limited scope where analysis of data requires evaluation of identifiable factors. Demonstrates potential for technical proficiency and scientific creativity
- Under the supervision of other scientists, carry out activities in support of the manufacturing of pharmaceutical products. These activities include compendial microbial testing of raw materials, in process materials, and finished products within scheduled timelines
- Perform environmental sampling and testing
- Perform USP water sampling and testing
- Perform identification of microorganisms
- Maintain notebooks within GMP standards and SOPs. Accurately report results, and provide detailed records of results and conclusions
- Provides written and verbal updates on projects and activities as required
- Is familiar with Quality Systems such as: Compliance Wire, Trackwise , Documentum
- Assist other scientists, as necessary, for timely project completion and support other lab personnel as required
- Comply with Health, Safety and Environmental responsibilities for the position
- 0- 5 years applicable industry experience preferably in pharmaceutical microbiology
- Working knowledge and application of scientific principles and aseptic techniques
- General knowledge of compendial microbiology requirements
- Experience with computer software associated with word processing and spreadsheets
76
Production Microbiologist Resume Examples & Samples
- Your other roles will include; isolation and storage of the symbiotic bacteria from the nematodes
- Creation of new culture lines as required
- Ensure all processes are completed to the highest standards in accordance with Health and Safety and Operating procedures
- A degree in Microbiology or other relevant Bioscience degree
- You will have previous laboratory experience either gained as part of your degree studies or in industry
- You must have excellent attention to detail and highly developed organization skills
- You will be a confident and decisive individual who is able to work on their own initiative as well as someone who works well as part of a team
- It is essential that you have a good working knowledge of Microsoft office software packages
- You should also have a good understanding of Health and Safety issues
77
Clinical Microbiologist Resume Examples & Samples
- Consults with medical supervision or attending physician staff members to identify microbiological tests considered necessary to aid in the diagnosis of patient illness in a particular hospital setting
- Analyzes requests for microbiological tests and determines what resources are necessary for their performance at various frequencies in terms of personnel, equipment, materials and other items of supply
- Decides whether the capability required for test performance at a projected frequency exists in-house and/or what action is necessary to produce such capability; initiates, with approval of medical supervisor, appropriate action to install tests in-house or arrange for performance at another laboratory
- Determines what specific equipment, media, and other materials and supplies will be used in the performance of individual microbiological test procedures
- Establishes the scope and nature of the quality control procedures necessary to assure the accuracy and reliability of test results, and continually monitors the performance of such procedures to assure their effectiveness
- Plans, develops, and conducts an on-going program of education and consultation with the attending physician staff to develop and increase their awareness and understanding of microbiology laboratory capabilities, resolve specific problems of microbial infection, and prevent epidemiological infection within the hospital
- **The required license MUST be current and unrestricted; a conditional, provisional, probationary, or restricted licenses and/or certificates will NOT be accepted
78
Computational Microbiologist Resume Examples & Samples
- Minimum of a PhD in Molecular Microbiology or related discipline
- Minimum of five or more years of relevant experience
- Experience with microbial genetics
- Strong skills in experimental design, analysis of bacterial communities using various ‘omics approaches and large data sets
- Knowledge of statistical and predictive analytics
- Strong technical and scientific writing (papers, reviews, or grant applications)
- Particular interest and experience of the soil / plant microbiome or microbial consortia
- Programming skills (Proficiency in at least one scripting language e.g. R/Python, parallel computing experience)
- Experience of operating cross-functionally in a matrixed environment
- Familiarity with working in the AWS cloud environment and/or Java/C++ programming
- Experience with microbiological culture with a particular emphasis on species recalcitrant to culture
- Microbial physiology experience including developing phenotypic assays
79
Microbiologist Resume Examples & Samples
- Education to include at least 10 semester credit hours or 15 quarter credit hours in microbiology
- One or more years work experience in a microbiology lab
- Familiarity with veterinary medicine
- Experience with medical or laboratory database
- Experience in sterile technique and handling biological specimens
80
Microbiologist Resume Examples & Samples
- 2+ years of experience with a Bachelor’s degree
- Demonstrates good laboratory/aseptic technique and practices
- Quality experience in an FDA-regulated laboratory environment preferred
- Experience successfully interfacing with government and accreditation agencies (FDA, ISO, AATB) and writing regulatory filings, responses and other documents required in a regulated environment
- Strong communication skills, both oral and written
- Skillful in formulating strategies, tactics and action plans to achieve results
- Strong focus on developing an organizational culture that fosters teamwork
- Ability to effectively influence key decision makers
- Ability to work well under pressure and maintain positive, enthusiastic attitude
81
Microbiologist Resume Examples & Samples
- Microbiological skills including
- Bachelor of Science in Microbiology, Biological Sciences, Food Sciences, or related
- 1+ years’ experience working in FDA regulated GMP environment in either a food or pharmaceutical microbiology laboratory setting preferred
- Good written and verbal communication skills, excellent documentation and organizational skills
- Demonstrated critical thinking skills, attention to detail, and the ability to work independently and as part of a high functioning team
- Ability to take ownership of assigned tasks and responsibility for the results
- Ability to work overtime as needed
82
Senior Microbiologist Resume Examples & Samples
- Main Responsibilities
- Minimum Bachelor’s degree in Microbiology, Biology, Food Science or related field
- 5+ years lab-based or industrial experience in microbiology, food safety, pharmaceutical QC, or biocide industries
- Experience building relationships and communicating with customers in a technical field
- QC or industrial microbiology experience preferred
- Mechanical aptitude associated with manufacturing or plant production environments
83
Microbiologist Resume Examples & Samples
- Travel for training and work assignments may be required
- Virus isolation and molecular tests including Polymerase chain reaction (PCR)
- Developing and conducting developmental projects for the purpose of improved reagents and diagnostic assays
- Developing and maintaining national and international expertise and collaborations in virus isolation, identification and genotyping
- Performing sequence comparisons
- Serologic or molecular test development or validation
- Project management and/or team leadership
- Collating data for presentation at scientific meetings and/or publication and writing peer-reviewed abstracts or articles
- This education must have been successfully completed and obtained from an accredited school, college, or university
84
Microbiologist Resume Examples & Samples
- Oversight of diagnostic microbiology testing including bacteriology, serology, virology and molecular diagnostics
- Conducts testing as needed
- Oversees quality control in microbiology section
- Supervises activities of subordinates
- Conducts performance reviews of subordinates
- Distributes workload among subordinates
- Oversees proficiency testing
- Communicates with laboratory clients regarding test requests and test results
- Works with the Quality Manager to assure compliance of the microbiology sections with the laboratory quality assurance system
- Develops, validates and implements new tests as needed to meet demands of laboratory clients
- Works with vendors to maintain equipment in the section
- Other duties as may be assigned by the Director
- Master’s degree in a relevant science related field with at least 2 years veterinary diagnostic laboratory or relevant work experience in the areas of bacteriology, serology, virology/molecular diagnostics, and parasitology
- Five years experience in a veterinary diagnostic laboratory or relevant work experience
- Supervisory experience in a microbiology laboratory
85
Microbiologist Resume Examples & Samples
- Perform laboratory tests such as infectivity neutralization, enzyme activity inhibition, PCR, ELISA
- Work with biological databases (e.g., EpiFlu)
- Perform sequence alignment and analysis
- Perform literature search to identify approaches that can be used for harmonization of laboratory data reporting (e.g. universal numbering system for reporting genetic markers of drug resistance)
- Update primers for pyrosequencing assay needed to detect known and suspected markers of drug resistance or markers of virulence
- Perform phylogenetic analysis
- Develop and maintain standard operating procedures (SOPs) for sequence data analysis related to antiviral resistance
- Oral and written communications to support ongoing efforts to connect various laboratory databases and streamline data reporting to customers
86
Microbiologist Resume Examples & Samples
- A Bachelor's degree or higher in Microbiology or another biomedical laboratory science provided that at least 20 semester or 30 quarter credit hours in microbiology are included
- Experience applying knowledge of various microbiology disciplines to modern instrumentation
- Experience participating in microbiological studies including instrumentation and method development
- Demonstrated experience present technical information clearly, both orally and in writing
- Experience in the following
87
Microbiologist Resume Examples & Samples
- Prepare bacterial culture media, grow cultures, and handle solutions and reagents
- Perform mammalian cell cultures and cell-based assays (including cytotoxicity and toxin neutralization assay)
- Work with blood, serum, and plasma samples, performing serological assays (ELISA and toxins neutralization)
88
Microbiologist / Senior Microbiologist Resume Examples & Samples
- Perform method transfers/qualifications for drug substances and other drug products
- Review SOPs and Protocols with relevant to Microbiology
- 0 to 6 years’ experience in pharmaceutical industry is preferred
- Previous OJT is preferred
- Experience in operating laboratory equipment and lab computer systems is very desirable
- Good oral and written communication skills
89
Senior Microbiologist Resume Examples & Samples
- Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. Compressed air and Nitrogen systems
- Perform personnel qualification and re-qualification and also to lead qualification and re-qualification of the clean rooms, when necessary
- Provide testing support to plant validation activities
- Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing
- Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures
- Perform periodic review of closed out Validation Document packages and Standard Operating Procedures
- Extend documentation support to the department by participating in writing/revising of SOPs, protocols, Test reports and any other work assigned by the Senior, Lead Microbiologist, Sr/ Manager, Microbiology
- Maintain continuous supply of laboratory consumables
- Supervise and oversee Third Party Contractors, where applicable
- Liaise with other department for training needs and technical support
- Liaise with vendor and service engineers/ESPs for equipment validation, calibration and maintenance work
- Maintain the Calibration and Preventive Maintenance Programme
- Review of compendial and corporate policy changes
- Prepare trend Reports
- Perform Qualification and validation of equipment
- Review and approve test reports log books, data sheets that are generated in microbiology lab
- Degree in Microbiology / Biotechnology
- 4 – 6 years’ experience in pharmaceutical industry is preferred
- The experience in operating laboratory equipment and lab computer systems is very desirable
- Analytical development mindset in research and commercialization activities
90
Microbiologist Resume Examples & Samples
- Generate appropriate sampling plans and continuously review them so as to meet the demands of the process. Ensure adherence to microbiology sampling plans
- Study process behaviour through QC results so as to advise staff on process capabilities and recommend necessary changes meant for improvement in quality and lowering of costs
- Initiate process investigations and surveys aimed at solving recurring process deviations
- Generate and implement appropriate sampling plans to meet process demands. Ensure adherence to microbiology sampling plans
- Plan and enforce yeast management to ensure smooth running of the process and quality conformance
- Ensure proper implementation of ISO management systems, LTO and other Legal requirements
- Plan for good Quality consumables and Equipment to ensure smooth running of the QC business function
- Bachelor of Science in Microbiology
- Over 2 years’ experience in Microbiology
91
Product Development Microbiologist Resume Examples & Samples
- Bachelor’s degree or higher in Science from an accredited institution
- Minimum of one (1) year of experience in Food Safety Microbiology in a laboratory setting
- Bachelor’s degree in Biology, Chemistry, Food Science or related discipline from an accredited institution
- Two years of experience or more using 3M™ Petrifilm™ Plate methods for indicator organism enumeration
- Excellent communication, data analysis, and computer
92
Microbiologist Resume Examples & Samples
- Plan, coordinate, execute, and/or oversee execution of Inspection Plans, Method Development, Method Transfers, Method Validations/Re-Validations, and Equipment Qualification/Re-Qualifications consistent with business timelines and with minimal supervision
- Create, revise, review, and approve Standard Operating Procedures, test methods, sampling plans, raw material and finished product specifications, laboratory validations, and facility/utility qualifications
- Train entry level lab analysts on Microbiological assays and techniques and aseptic production operators requiring aseptic technique and environmental monitoring training
- Write and execute test protocols, compile the data, and write the final reports to support validations and re-validations
- Represent Micro Quality Control function as a team member on Validations, Engineering/Maintenance Engineering Unit, Production, Project Management, Research & Development and/or laboratory projects providing technical and compliance input
- Review data packets, determine disposition, and perform Quality Control release/reject in SAP as required assuring data is compliant and entered timely and appropriately
- Assist, as needed, in routine testing activities within the laboratory and routinely schedules laboratory weekly requirements. Provide oversight of specific test areas within the lab, which may include any of the following; sterility, endotoxin, particulate, bio-burden, growth promotion/media prep, environmental monitoring, and identification
- Report results of activities to supervisor on a regular basis and may act as a representative on behalf of supervisor with regards to representing Micro Quality Control functions during regulatory and/or client audits and assuring operations within span of control are compliant with regulatory requirements, such as International Standards Organization, European Union, United States Pharmacopeia , Current Good Documentation Practice’s, and Bayer Global Policies and procedures
- This position requires B.S. degree in Biological Sciences, preferably Microbiology, with minimum of 5 years of Pharmaceutical Microbiology Laboratory work experience with background in test method development and method validation/re-validation, aseptic processing and sterility assurance
- The incumbent must have strong interpersonal, written, and verbal skills. The incumbent must be able to interface positively with peers, clients, regulatory agencies, vendors, and staff from other departments. The incumbent must be able to make routine decisions concerning the suitability of test material, data, and equipment to ensure accuracy and compliance
- The incumbent must possess a broad knowledge of microbiological procedures and methods and must be familiar with Current Good Documentation Practices, International Standards Organization regulations, and the Compendia methods of the United States Pharmacopia, European Pharmacopia, as well as appropriate guidelines for performance as they relate to method development, method validation, and routine testing
- This position supports the overall manufacturing processes of the facility and may be required to work some evenings or weekends to ensure certain validation, production or other facility and laboratory requirements are met in a manner that supports the requirements of customers and the business
- Bayer Core Competencies: Drives Results, Collaborates, Plans & Aligns, Manages Complexity, and Customer Focus
93
Junior Microbiologist Resume Examples & Samples
- National Diploma in Biotechnology or equivalent
- Minimum of 1-2 years’ experience in a micro laboratory or similar environment
- Candidate must be numerically literate, mustbe fluent in English (written and verbal )
- Good communication and good interpersonal skills
94
Microbiologist Resume Examples & Samples
- Experience in a manufacturing environment
- Microbiological testing lab experience in the pharmaceutical industry
- Ability to work off shift, holidays and facility shut downs
95
Senior Microbiologist, Quality Resume Examples & Samples
- Perform / evaluate sterilization studies, validations and revalidations in support of sterile devices and validated processes. Plan, lead, track and complete broad projects toward goals in support of medical device manufacturing and sterilization
- Possess knowledge and understanding of sterilization processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance
- Bachelor’s degree in Microbiology or equivalent and minimum of 5 years of experience including Ethylene Oxide (EO) sterilization. Relevant experience in radiation (Gamma and E-beam) or other modalities and experience in a microbiology laboratory
- Experience with microbiological testing of medical devices, manufacturing processes, systems, and facilities. Microbiological qualification involving sterilization processes, and environmental controls and microbiology laboratory testing
- Moderate knowledge of laboratory test method validation
- Knowledge of Good Manufacturing and Good Documentation practices supporting medical device manufacturing
- Ability to interact at the highest professional manner with all organizational levels
- Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to team environment / outside departments and externally
- Proven experience working with and understanding requirements for sterilization with knowledge of relevant ISO standards is strongly preferred and experience with regulatory compliance
- Must have aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes. Microbiological identification and characterization
- Experience with conducting investigation, developing corrective and preventative (CAPA), and product impact assessment
- Computer skills: Word, Excel, Project, Visio, LIMS
96
Microbiologist Resume Examples & Samples
- Leading the microbial characterization of microbial seed treatment formulations and the evaluation of their interaction with the seed
- Working collaboratively across Monsanto to arrange and conduct testing supporting current commercial products, as well as the development and advancement of new formulation candidates. This will require effective interfacing with not only those in R & D, but also others in manufacturing, QA/QC, regulatory, marketing, and commercial
- Evaluating and implementing new technologies to enhance current capabilities
- Providing technical reports and presentations to enable company-wide and industry adoption of new methodologies
- Limited travel to Monsanto field and manufacturing sites to support testing of existing commercial. products and new formulations candidates, as well as for the transfer of testing methodologies
- Minimum of a PhD in Microbiology, Biology, Chemistry or related field of study
- Experience in microbiology testing
- Experience in microbial fermentation and microbial physiology
- Knowledge of experimental design and statistical methods
- Scientific, yet practical approach to problem solving
- Ability to work on cross-functional and international teams and to prioritize and manage the demands from multiple projects
- Two or more years of related industry experience
- Prior experience with microbial formulations or seed treatments including evaluation of aging and stability characteristics
- Ability to optimize and automate routine microbiology testing
- Ability to develop and implement advanced microbial test methods
97
Senior Microbiologist Resume Examples & Samples
- Advanced knowledge of current guidelines and methods pertaining to microbiology/sterility assurance
- Minimum eight years previous experience in field of biosciences required
- Complete understanding of industry and regulatory standards required
- Experience in working in a CRO is preferred
98
Microbiologist Resume Examples & Samples
- Demonstrate Safety as a value by performing all job functions safely, while complying with corporate and site policies and procedures, to reduce risk and eliminate loss
- Bachelor’s Degree in Microbiology with at least 2 years of post-graduate experience in Microbiology, food microbiology, biochemistry, or a related field
- 2 years of Cosmetic Regulatory compliance, or other regulated field
- 2 years of aseptic Quality Lab operation experience in a manufacturing or medical environment, or equivalent
- Understand Good Lab Practices and regulations. Familiar with cleaning and sanitization validation approaches. Understand the importance of document control and record management requirements
- Strong trend analysis and attention to details. Excellent Microsoft, SAP and Quality System computer skills to update detailed specifications, create pivot tables, etc
- Demonstrated effective leadership skills. Problem solving leadership skills required to work with cross functional staff/site team members to drive continuous improvement
- Self-motivated; works with little to no supervision
- Must be able to work 8 hours per day and two weekends per month, with flexibility to work nights, holidays, and overtime as needed
- 2 years Microbiological Lab Experience in cosmetic manufacturing setting
- Must demonstrate proficiency in the following: Quality System computer analysis, document control system (Example: ETQ Excellence through Quality)
99
Microbiologist Resume Examples & Samples
- Perform the routine/non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test
- Perform in-process and release samples testing of excipient/ packaging components for the different drug products, semi finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden test, Microbial Limits Test, etc., as appropriate
- Perform routine and Batch related Environmental monitoring in clean rooms and other production areas and laboratory
- Perform microbial identification (Bacteria, mold and yeast) in water, environment and product samples
- Liaise with external vendors on instrument calibration and maintenance
- Solicit quotations of laboratory consumables
- Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable
- Need to co-ordinate with Quality, respective Plant Operations, Projects and Engineering & Maintenance
- Need to coordinate with suppliers of microbiological media and other equipment
- Any other duties as assigned by the Supervisor / Manager
- 1 – 3 years’ experience in pharmaceutical industry is preferred
- Good understanding of Safety and cGMP practices
100
Microbiologist Resume Examples & Samples
- Microbiology Research and Testing – Plan and conduct a variety of experiments and tests using best practice methods in support of designated new product developments. Involves working to agreed schedules that support challenging project timeframes
- Data analysis and reporting -Using agreed formats, record experimental data and prepare reports on work undertaken. This includes presenting initial analysis, conclusions and recommendations as a basis for further discussion and research
- Problem Resolution -Work to resolve technical/scientific problems in a timely manner by collaborating with other wound biology functional experts. Participate in related discussions that identify relevant theory and practical interventions
- Functional/Technical Expertise- Develop and maintain understanding of the latest microbiology theories and research initiatives and make recommendations internally about any related changes to current methods and working practices. Develop and share expert functional knowledge, educating individuals across both NPD and the wider AWC team. Maintain a network of internal contacts who can defer to for advice when appropriate
- Degree required in relevant scientific discipline
- Experience of microbiology research and development ideally in a commercial environment
- Knowledge/experience of microbiology testing methodologies, standards and best practice
- Ability to clearly convey technical information and ideas to a variety of individuals and groups with different levels of understanding
- Ability to work effectively in a collaborative environment in a complex matrix organization with minimal supervision/guidance from management
- Must work in strict accordance with the policies and procedures of BS EN ISO9001 and GLP
- Computer literate with specific knowledge of Microsoft Office applications
101
Microbiologist Resume Examples & Samples
- Administration of the laboratory (Manage the day to day lab activities, Purchasing External Services & Supplies)
- Maintaining quality procedures (Control systems (Quality Manual and QC SOP’s))
- Arranging internal audits
- Arranging management review meetings
- Familiar with all lab techniques/methods and technology
- Micro testing of Finished Products, in process and raw materials
- Validate and update test methods
- In charge of Receipt, Storage, Retention & Disposal of Mars Samples
- Manage and monitor lab equipment, cleaning, maintenance and calibration
- Manage & monitor Lab inventory
- Reporting Results/data management
- Data processing (Document Control )
- Molecular biology techniques skills (PCR, ELISA, PFGE, sequencing)
- Laboratory quality control checks (daily positive control, hygiene, media, sterilization, environmental (take the swabs from the lab), personal hygiene, etc.)
- Control of Non-Conforming Work & Corrective Action
- Manage the Preventative Actions & Continues Improvement program
- Assuring the Quality of Test Results
- Responsible for implementing ISO 17025
- Final Sign off of Reporting Results
- Manage Proficiency tests (and participate)
102
Microbiologist Resume Examples & Samples
- Develop and follow Laboratory Standard Operating Procedures which must be based on Good laboratory Practices (GLP’s)
- Adopt microbiological methods which are prescribed in the official compendium (e.g. AOAC, AACC, FCC, USP, BP, etc.)
- Test raw ingredients, finished products and environmental samples
- Testing of finished products using pour plate, petrifilm and rapid micro test methods for sterility
- Monitor plant and laboratory environment by taking swabs, air and water samples at set frequency
- Participate in the AOAC proficiency testing.(Including: performing specific tests, expressing the results in a described manner, monitor response time)
- Provide Month end statistical information to QATM, Process Documentation Supervisor and Plant Manager
- Maintain registration of the laboratory permits
- Maintain clean equipment and laboratory environment
- Calibrate laboratory equipment
- Provide recommendations and feedback on testing results to management
- Evaluate and authorize the stability of raw materials and finished product
- Review all laboratory programs regularly and keep records
- General support of plant production and quality assigned by plant leadership
- Attend all safety meetings, report any safety incidents/accidents and understand and follow all Company and Plant Safety policies and Procedures
- Trained in the Kerry HACCP program in order to identify critical steps and other instructions critical to effective implementation and maintenance of the Food Safety Plan
- Provides support for the current SQF System
- Manager micro laboratory supplies (inventory on a set frequency)
- Communicate with lab suppliers and order supplies when necessary
- Leadership in the fundamentals of lab safety, equipment and testing procedures
- Provide support to plant employees in aseptic sampling process and food safety
- Meet the efficiency and cost targets of the department
- Evaluate product from shipment or production
- Set up and order micro testing materials
- Schedule environmental testing
- Maintaining technical proficiency through participating in training and development courses as provided by LMS
- Adhering to the ethical standards as outlined by Kerry USA
- Participation in continuous improvement projects and suggestions organized by plant management
- Participation in cost savings initiatives
- Participation in courses provided by GFTC, Silliker or other leaders in microbiology or organized by the Corporate Microbiology Task Force
- 3 years of experience in the microbiological laboratory
- Knowledge of pathogen confirmation tests
- Experience utilizing Aseptic Technique
- Full understanding of biohazards and laboratory safety
103
Corporate Plant Hygienist / Microbiologist Resume Examples & Samples
- Collect relevant microbiologically focused data to evaluate current plant sanitation procedures and recommend corrective actions to reduce the identified hygienic risk
- Manage plant focused hygienic investigations and suggested documented corrective actions
- Evaluate plant sanitation activities / procedures and recommend relevant continuous improvements
- Evaluate microbiologically focused concerns and recommend corrective actions
- Provide reports to senior management on the hygienic performance of company owned plants and contracted manufacturing sites
- Two to three years of food plant sanitarian experience with an emphasis on microbiological evaluations and controls
- Previous food industry experience, which includes HACCP, SQF (or other GFIS), and FSMA preventive controls
- Knowledge of effective sanitation protocols and prior training in fundamental quality assurance
104
Microbiologist Resume Examples & Samples
- Perform all functions relating to sample preparation through sample completion
- Perform confirmation work
- Provide training on applications as needed
- Perform project work as needed
- Able to troubleshoot work
- Create and revise forms, work instructions or SOP’s with guidance
- Plan for assigned workload on a daily basis and effectively schedule multiple assignments
- Maintains a clean and safe laboratory work environment
- Facilitates the work flow for other microbiologists in the lab
- Reviews sample login prior to samples testing being initiated in the lab
- 3 – 5 years
105
Associate Microbiologist Resume Examples & Samples
- 1-3 years of experience in a Microbiology Lab with at least 1 year in a Medical Device environment
- Customer Focus
- Ethics & Values
- Managing an Measuring Work
- Decision Quality
- Informing
- General knowledge of cGMP’s/ISO 13485: 2003
- Validations
- Computer Software Knowledge (Word, Excel)
106
Senior Microbiologist Resume Examples & Samples
- Bachelor’s degree required in Microbiology or other related science
- 4+ years of experience in the medical device/pharmaceutical industry pertaining to microbiology/sterilization with a Bachelor’s degree
- 2+ years of experience in medical device/pharmaceutical industry pertaining to microbiology/sterilization with a Master’s degree
- Understanding and application of current sterilization standards, such as ISO 11135 and ISO 11137
- Knowledge of sterilization technologies and processes, especially EO, steam, and radiation
- Familiar with FDA 21 CFR part 820 and 210 and ISO 13485
- Master’s degree in Microbiology or other related science preferred
- Ability to develop, validate, implement and defend business processes that impact sterilization. Demonstrate verbal and written, and presentation skills
- Proficiency in sterilization sciences
- Ability to effectively communicate at all levels
- Well-developed computer skills with expertise in Word, Excel, PowerPoint and statistical tools
- Must be an effective team player intra-departmentally and cross functionally
- Leadership skills that include project management, training and presentation, and the ability to champion teamwork
107
Microbiologist Resume Examples & Samples
- Answer incoming calls from clients, physicians, and nursing staff
- Analysis of various body fluids relating to the fields of chemistry, serology, toxicology, special chemistry, urinalysis, coagulation, and cell counting to aid in diagnosis of certain disease states
- Preferably 3-5 years previous full time Microbiology experience
108
Microbiologist Resume Examples & Samples
- Test finished products and environmental samples
- Develop and follow Laboratory Standard Operating Procedures which must be based on Good laboratory Practices (GLP’s
- Responsible for supporting quality functions including food safety systems and programs along with compliance
- Supports quality staff in quality supervisor and/or quality managers’ absence
- Conducts laboratory analyses and investigations
- Demonstrates knowledge of product and processes, and their impact on overall quality
- Provides technical assistance to quality function and operations
109
Microbiologist Positions Resume Examples & Samples
- A Bachelor's degree or higher in Molecular Biology, Microbiology, Biochemistry, Biotechnology, Cell biology, Biology or another basic medical science, WHICH INCLUDES20 or more semester hours or quarter hour equivalent in microbiology, and other subjects related to the study to microorganisms
- Demonstrated experience in the following
- Working in a public health or clinical laboratory
- Using computer skills to analyze data
- Quickly learning and understanding new technology and methods
- Analysis and problem solving
- Presenting technical information clearly, both orally and in writing
110
Microbiologist Resume Examples & Samples
- Microbiology degree or degree in a related biological discipline (with microbiology content) or equivalent
- Proficient in the use of numerous Laboratory instruments, software packages and microbiological techniques
- Good organisational skills
- Experience in Environmental Monitoring and Microbial Limit Testingproficient in the use of numerous Laboratory instruments, software packages and microbiological techniques
- Good aseptic technique
- Understands microbial control requirements of dosage forms
- Is computer literate and competent in the use of Microsoft packages
- May have experience of equipment or method validation
- Basic understanding of water systems
- Experience of various microbiological identification techniques
- Experience in laboratory investigations
111
Senior Microbiologist Resume Examples & Samples
- Product preservation experience gained in the field of Consumer Healthcare product development
- Proven record of supporting business objectives
- Demonstrated skill in project participation or management
- Demonstrated ability to take initiative, think and work independently, problem-solve and work effectively in teams
- Excellent written/oral communication skills, interpersonal relationship building and team working skills
- Experience working across more than one sector or category (pharmaceuticals, cosmetics, oral care products and nutritional products)
- Experience of working across functional interfaces as well as with external contractors (e.g. third party laboratories)
- Good knowledge of Regulatory, GMP’s and ISO Quality management system standards
- Define the strategy for preservation of the products developed by the Consumer Health organization. Monitor external regulatory trends that have the potential to impact product preservation
- In collaboration with stakeholders in R&D and manufacturing, provide technical input to project teams on microbiological issues throughout the project lifecycle
- Ensure that state of the art microbiological test methods are employed in the CH organization, with the goal of continual improvement of effectiveness and efficiency
- Ensure application of robust and valid scientific approaches to all work conducted in internal and external laboratory networks. Lead laboratory investigations including those related to OOS / OOT results
- Maintain technical knowledge for Microbiology Pharmacopeia requirements. Prepare documentation for internal use and regulatory submission including, SOPs, technical reports and dossier modules
112
Microbiologist Resume Examples & Samples
- Be accountable for all meeting all assigned Quality Engineering deliverables
- Ensure the quality of products produced at Playtex Business Unit is consistent with EPC / Playtex Mfg. Inc. Quality standards
- Ensure the Quality Unit is functioning efficiently by assessing current processes and identifying ways to streamline or improve
- Ensure the timely closure of Corrective Action Preventative Action (CAPA) investigations, on-going investigations and other non-conformance investigations
- Support appropriate product development quality related projects: internal and external
- Communicates effectively with internal and external customers and support groups to resolve quality issues
- Creates and presents reports for management, and other internal groups. Reports include trip, audit, and current status
- Ability to effectively communicate with cross functional groups located both externally and internally within the organization
- Knowledge of problem solving technical problems in a structured method
- Perform statistical analysis on data sets and be able to interpret results
- Conducts quality audits on appropriate regulatory and procedural requirements
- Ability to motivate closure of open Corrective Action Preventative Action (CAPA) incidents
- Ability to write, review, updates and approves Quality SOP’s
- Perform and report microbiological tests to support manufacturing (both in-house and contract), validations, environmental monitoring, etc
- Ensure completion of all laboratory investigations including documentation
- Ensure laboratory equipment preventive maintenance is completed on schedule. Monitor completion of the laboratory equipment calibration schedule
- Assist as needed in the validation and/or qualification of laboratory equipment
- BA or BS preferable in Biology, Microbiology or related field
- Two to five years minimum experience working in a microbiology laboratory environment, if BS
- Zero to two years minimum experience working in a microbiology laboratory environment, if Master
- Two to five years minimum experience in an FDA regulated business or ISO:9000 Quality System
- ASQ CQE certification or Six Sigma Green Belt preferred
- Process or Packaging validation a major plus
- QC laboratory experience a plus
- Knowledge of CFR 210/211 or CFR 820
- Excellent computer skills – Microsoft Office
- Well organized person
- Strong problem solving skills, including root cause analysis
- Strong statistics and sampling plans background with DOE experience a plus
- Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 5%, or slightly more, of their work time
113
Microbiologist Resume Examples & Samples
- Act as the point of contact for routine microbiology technical service activities
- Use standard microbiological techniques to enumerate and identify microorganisms in unknown samples
- Conduct microbiological assays in accordance with Standard Operating Procedures
- Use critical thinking skills and process innovation to continuously improve procedures
- Demonstrate initiative and ability to work independently, as well as in a team environment, often operating as a self-starter
- Collect and analyze data, summarizing findings in written reports
- Utilize and develop proficiency in Laboratory Information Management System (LIMS)
- Represent Global Analytical and Microbiological Services in a competent and professional manner for customer tours and in other interactions inside and outside Ecolab
- Bachelor’s degree in Microbiology, Biology, Food Science or related science
- 1+ years of lab-based experience in microbiology, food safety, or pharmaceutical QC industries
- Industrial microbiology experience
- Demonstrated ability to manage multiple projects and meet deadlines
114
Laboratory Technician / Microbiologist Resume Examples & Samples
- Ensuring of quality control of incoming raw materials, semifinished and finished products in line with MDLZ specifications and legislation requirements
- Verification of product food safety and quality, hygienic and sanitary conditions in production and non- production areas
- Execute work in line with IMS (Integrated Management System) requirements and valid MDLZ policies and documents. Keep all safety and security rules determinated for safety, protection of health at work, protection of property, environment and food safety in line with valid legislation and MDLZ SK a MDLZ International requirements
- Follow GLP rules and prescribed microbiological laboratory procedures according to MDLZ Global Microbiological Manual requirements
- Ensure product food safety and quality by means of laboratory control of raw materials, semifinished and finished products, control of environmental conditions in production and non-production areas in line with ISO 9001:2000, MDLZ International, MDLZ SK and SK legislative requirements
- Ensure sampling of raw materials and environmental samples for microbiological control as well as archiving of back-up samples
- Keep and maintain precise records (analyses performed, results obtained) in SAP/KPA system
- By means of computer in follow and evaluate the trends in results
- Ensure proper disposal of infectious materials, preparation of sterile lab materials
- Ensure all extra microbiological analyses
- Participate on activities focused on the next professional development in HACCP and quality assurance areas
- Secondary school focused on Food Microbiology
- Practical training experience 2 years required
- Must have good Laboratory Practice
- Handling with laboratory infectious materials
- Knowledge of microbiological methods and procedures used
- Strong PC skills - Word, Excel
- Competence of food sensory assessment
- Fluent in English - both spoken and written
- Fluent in Slovak - both spoken and written
115
Oilfield Microbiologist Resume Examples & Samples
- Perform testing in a laboratory research environment – work on product formulations, sample preparation, and testing of oil and water samples to support technical service projects
- May participate in customer interface with team leader
- Provide technical product support and service
- Analyze data and communicate results through presentation and documentation to various groups
- Travel to field to implement recommendations made as a result of testing
- Help develop and test new products with senior scientists
- Handle special projects as assigned
- Bachelors degree in one of the natural or physical sciences
- 1 to 3 years experience in the oilfield industry
- Motivated, self-starter
- Attention to detail but with an sense of urgency
- Ability to multi-task to work on multiple projects
- Work independently at times, but also function as part of a team to complete large projects
- Experience with Production Chemicals - examples (Scale, Corrosion, Bacteria Control, Wax, Hydrate, Paraffin)
- Experience in microbiology or other biological sciences
- Specific experience in oilfield microbiology (Serial dilution enumeration, ATP, etc.)
- Intermediate analytical skills
- Ability to communicate well individually and in team environment
116
Microbiologist Resume Examples & Samples
- Perform testing of raw material, in-process and finished product samples according to Bayer procedures
- Perform Environmental monitoring of the manufacturing and laboratory facilities including cleanroom environments, personnel, water systems, compressed gases, and laminar flow hoods
- Identify microbial isolates using manual or automated techniques per written procedures in a timeframe that supports customer requirements
- Prepare media, solutions, materials and equipment to support sampling and testing
- Perform growth promotion and quality testing on media used for microbiological testing, environmental monitoring and sterility testing in the Microbiology QC Department as needed
- Maintain the record storage systems in a manner that ensures quick and reliable retrieval of the data as needed
- Provide support to laboratory projects and assist other team members as needed
- Adhere to the pertinent aspects of corporate compliance and plant safety programs
- B.S. degree in Microbiology or a biological science degree with Microbiology coursework
- Pharmaceutical microbiology experience is required
- Must have well-developed communication and interpersonal skills and the ability to work independently and with others in a team situation
- The incumbent must be able to follow directions, both verbal and written
- This position will be considered off-shift with hours of 12:00pm to 8:00pm Monday through Friday
117
Microbiologist Resume Examples & Samples
- Bachelor’s and/or advanced degree in microbiology or closely related field of study
- Work experience with medical or laboratory data base(s)
- Experience handling biological specimens,
- Experience working with automated lab testing procedures, i.e. fecal floats
- Work experience in a diagnostic laboratory setting
- Familiarity with Veterinary Medicine
- Experience in quality control / quality assurance in a medical (animal health,
118
QC Microbiologist Resume Examples & Samples
- Completes daily assigned routine tasks timely and accurately (may include collection and/or testing of GMP samples, reporting of data, general lab housekeeping)
- Paperwork review, data entry, filing, etc
- Generation of data reports and/or trends
- Serves on team projects in the role of testing support, as needed
- Provides training to staff
- Identifies areas for improvement or gaps
- Effectively communicates issues/hurdles to team lead and/or manager
119
Microbiologist / Micro Technician Resume Examples & Samples
- Maintains requirements for ISO 17025 (International Organization for Standardization, global quality standard for testing and calibration laboratories)
- Develops, documents, updates, and maintains Lab SOPs and approved procedures
- Identifies and evaluates new methods for detecting, enumerating and identifying microorganisms of concern
- Generates monthly reports describing laboratory activities, trends, learnings and expenditures
- Maintains and calibrates laboratory equipment as well as a clean laboratory work environment
- Prepares and edits technical reports
- Performs other assorted duties related to quality assurance, research, and laboratory operations as assigned
- BS Degree with major studies in Biology, Microbiology, Food Science or Biochemistry required. MS preferred
- Minimum 3 years related laboratory experience
- Proficient in Microsoft Word and Excel
- Knowledge of food safety, food development processes, and aseptic technique
- Knowledge of molecular microbiology techniques including PCR, RT-PCR, genetic subtyping, etc
- Ability to critically examine and follow technical procedures
- Capacity to collect and analyze data using basic statistics, draw conclusions based on facts, and write concise reports
- Ability to work in an environment of changing priorities and levels of intensity
- Capability of working independently and with limited supervision, as well as working with others as a member of a team
- Sound interpersonal and relationship skills
- Experience presenting and communicating scientific data to many audiences
- Travel to plant locations as necessary
120
Microbiologist Resume Examples & Samples
- Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and
- Iocompatibility analysis of medical devices
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products
- Lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ)
- Be the subject matter expert and point of contact for suppliers for new process development, quality issues and process improvements for assigned projects
- Review/approve product and process change control documentation and specifications
- Review/approve nonconforming material and system documentation
- Act as mentor to others
121
Microbiologist Resume Examples & Samples
- Applies fundamental technical skills to provide support and services for product and process development in a manufacturing environment
- Assists in maintaining Food and Drug Administration (FDA) compliant microbiology labs
- Provides microbiology support testing for raw materials, in-process, packaging, and finished drug and food products
- Provides stability sample testing according to SOP’s and United States Pharmacopeia (USP)/European Pharmacopeia EP requirements
- Performs Environmental Monitoring and Purified Water sampling, testing and trending evaluations
- Provides technical expertise in the development of specifications, test methods and standard operating procedures relating to microbial testing for current and future product introductions
- Supports Test Method validation and / or Transfer from internal or external labs
- Performs routine Microbiological analysis and other current Good Manufacturing Practices (cGMP) related duties as assigned
- Supports New Product Introduction (NPI) project transfer and manufacturing scale up
- Bachelor’s degree or higher in a Science discipline from an accredited institution
- Experience in aseptic laboratory techniques (an Internship or Co-op experience is considered qualifying)
- Bachelor’s degree or higher in Microbiology, Molecular Biology or related discipline from an accredited institution
- Previous experience in a microbiology laboratory (pharmaceutical, clinical, or industrial)
- Experience working in a manufacturing setting and pace
- Demonstrated understanding and utilization of pharmaceutical cGMPs, Good Laboratory Practices (GLPs), and Good Documentation Practices (GDPs)
- Skills include proficiency in Test Method Validation, Statistical Techniques, Project Management
- Experience in USP and International Organization for Standardization (ISO) testing procedures, including USP/ and ISO 11737
- Operational and basic troubleshooting skills related to microbiological methods and instrumentation
- Detail oriented with excellent problem solving skills
- Proven organizational and time management skills. Able to coordinate multiple tasks/projects and manage priorities accordingly
- Microsoft Office proficient, Minitab a plus
122
Clinical Microbiologist Resume Examples & Samples
- Training should have included at least12 months in a structured training program with clinical internship in a hospital setting
- Mustdemonstrate commitment and adherence to STHS's Compliance Program and Code of Conduct through compliance with all policiesand procedures, the Code of Conduct, attendance at required training and immediately reporting suspected compliance issue(s) to the Compliance Officer
- Techs newly certified as of 2004, are required to participate in a Certification Maintenance Program to continue certification every 3 years. Failure to participate will invalidate certification after the initial 3 year certification period
123
Microbiologist Resume Examples & Samples
- Has at least 1 year experience in a Pharmaceutical microbiology setting
- Is highly proficient in key analytical skills including laboratory instruments, software packages and other analytical techniques
- Is proficient in problem solving and has expertise in troubleshooting analytical equipment
- Has a good understanding of microbiological control requirements of dosage form
- Is aware of relevant national/international Pharmaceutical regulatory authorities
- Is competent in the use of basic Lean Sigma tools and aware of the Quality Management System
- Good Aseptic technique
- Microbiology experience from other industries – Food, consumer health, healthcare etc
- Specialised expert knowledge in one or more disciplines, such as EM, MLT or ID
- Basic understanding of water systems and environmental monitoring
124
Microbiologist Resume Examples & Samples
- Performs challenge tests to determine preservation effectiveness in research,
- Pilot and production samples
- Performs microbiological tests on raw materials, bulk, and finished goods to
- Determine microbiological content and composition
- Isolates and cultures bacteria and other microorganisms. Identifies
- Microorganisms by microscopic examination and chemical analyses of
- Substances produced by these microorganisms
- Reviews test results with immediate supervisor and maintains files and records
- Investigates, evaluates and implements new laboratory techniques
- Assists immediate supervisor in other functions and duties as assigned
- Screen raw materials for anti-microbial activity
- Formulate emulsions, gels and other cosmetic preparations
- Knowledge of Windows based computer programs
125
Biogeochemical Microbiologist Resume Examples & Samples
- Bachelor's degree with at least 7 years experience or a Master's degree with 5 years experience or a PhD with 3 years
- Must be a technical expert who selects and widely applies principles, theories and concepts in a major field of specialization
- Education/Experience: PhD in an area of microbiological or environmental science with at least 7 years’ experience. Demonstrated ability to attract and carry out R&D programs as evidenced by funding and publication record
- Technical Expertise: Ability to lead integrated research activities in support of existing and future projects, with responsibility for overall technical approach and execution
- Level of Responsibility: Operates independently to design and oversee tasks, responsible for meeting task scope, schedule and budget in cooperation with project manager. The candidate will also be expected to lead or co-lead proposals for externally funded projects, and engage in client interactions and project reviews
126
Microbiologist Resume Examples & Samples
- Oversee the testing of raw material, in-process and release testing using a variety of microbiological techniques (microbiological plating, water sampling and testing, Environmental Monitoring, Gram Staining, media preparation, etc)
- Oversee microbiological troubleshooting, method transfers and method optimization
- Oversee Inventory Management for chemical reagents, supplies, consumables, etc
- Follows cGMP, USP and 21CFR 210/211 requirements for laboratory testing and OOS investigations
- Technical knowledge of microbiological techniques
- Good computer skills. Proficiency with Word and Excel. LIMS experience a plus
- Ability to apply advanced statistics and compare data trends
- Effective verbal / written communication, interpersonal, and team-building skills
- Excellent organizational, problem-solving, prioritizing and follow-up skills
- Ability to handle multiple tasks / projects simultaneously
- Act as Laboratory Lead in Supervisor’s absence
- Conduct nonconformance / OOS investigations and participate in team root cause analysis
- Maintain laboratory audit readiness
- Train and develop personnel
- Oversee direct reports in the microbiological laboratory
- AA Degree with 6 years experience, BS Degree with 4 years experience or MS Degree with 2 years experience in an OTC Manufacturing laboratory
- Working knowledge of cGMPs as applicable to laboratory environment
- Extensive experience with identification and out of specification investigations
- High degree of problem solving skills, including root cause analysis
- Knowledge of statistics
- Must be able to read, write, and understand English
- Must be able to follow and communicate verbal and written instructions effectively
- Excellent Document Control skills
- Must be able to lead a staff of up to five individuals on a shift
- Must be able to work off shift and weekend hours
- SAP, Microsoft Excel, Word, Access, Agile and SharePoint experience
- Ability to maintain a high level of confidentiality
- Ability to work in a dynamic, stressful environment and be self-motivated
- Ability to change directions, remain flexible and respond quickly
- Minimum of 5 years hands-on experience supporting cGMP manufacturing environment
- Minimum of 5 years hands-on experience in a leadership role in a laboratory environment
127
Associate Microbiologist Tuesday Resume Examples & Samples
- Test raw materials and finished products for microbial contamination
- Assist in trouble shooting production problems
- Provide assistance in training personnel
- Prepare and standardize all reagents
- Calibrate and maintain laboratory equipment
- Validate procedures used in the micro lab
- Complete all necessary documentation in microbiology lab to ensure GMP (Good Manufacturing Practices) compliance
- Associate Microbiologists are responsible for and empowered to stop an analysis that may produce poor quality results as required by ISO 17025
- Demonstrates practical problem solving skills and the ability to carry out responsibilities under general supervision
- Able to manage time and organize workload for effective implementation
- Strong customer and results orientation
- Interacts effectively at all levels with sensitivity to cultural diversity
- Functions as an effective team member
- Adaptive, evolves with the changing external environment and organization
128
Senior Quality Microbiologist Resume Examples & Samples
- Operations Support -- Provides operational support and analytical problem solving at Supplier and Clorox locations, drawing on internal and external experts as appropriate, managing improvement plans and activities. Ensure practices are in place and standardized in our field and Corporate operations, including plants, suppliers and contract packers, to assure that stable conditions exist that prevent unacceptable microbiological contamination. Performs microbiology, environmental, and sanitation audits and testing. Conducts swabbing of manufacturing equipment and surfaces to validate sanitation SOP's - 50%
- Project and Lab Support -- Supports microbial inoculated challenge studies to ensure formulations are stable and robust. Trains plant & corporate personnel on microbiological and analytical methods. Provides approval for validation aspects of new equipment, products & processes. Coordinates testing with third party laboratories if necessary. Performs risk assessment of new raw materials. Ensures the lab is well maintained, organized, and capable of supporting current and future business needs. - 30%
- Drive Continuous Improvement - Supports the continuous improvement of the Quality function by identifying and resolving gaps/waste in quality systems, tools, and processes. Identified as the SME for key Quality processes to ensure they are effectively managed, standardized, maintained and continuously improved. Drives commonality of programs and processes at all manufacturing locations, including co-packers, where applicable -- 20%
129
Microbiologist Resume Examples & Samples
- Perform microbiological methods such as bioburden testing, microorganism identification, and endotoxin testing,
- Support the Sterilization Microbiologist in assuring consistent microbiological methods across the company
- Provide clear written procedures for routine microbiological methods
- Perform other duties as assigned based on business needs
- Education or Equivalent Experience: Bachelor's in Microbiology or similar degree
- Experience: 3-5 years of experience
- Demonstrated accomplishments in performing Sterilization and Microbiology activities
- Outstanding written and verbal skills
- Experience in supporting sterilization activities
130
Principal Microbiologist Resume Examples & Samples
- BSc Degree in Microbiology or related sciences with significant industry experience OR MSc Degree in Microbiology or related sciences
- Ability to apply scientific principles and techniques to assigned projects
- Experience of providing technical coaching to junior members
- PhD
- To provide Preservation expertise for the new product development in the five therapeutic categories with GSK Consumer Healthcare
- To ensure the Microbiology input of the product development is in line with the relevant regulatory and legislative requirements
- To provide technical training for members of internal Microbiology team as well as extended contract laboratory network (as required)
- Define the strategy for preservation of product developed by the Consumer Health organization. Monitor external regulatory trends that have the potential to impact Consumer Health preservation
- Ensure Category R&D teams are aware of microbiological issues and risks associated with category products and that these issues are addressed in product development programs
- Prepare in-depth risk assessment for all new product development and provide Microbiology expert summary for Regulatory submission
- Ensure compliance with Quality systems as well as health and safety requirements for all work conducted
- Providing coaching and mentoring for microbiologists and personnel involved in microbiological decision making
131
Senior Microbiologist Resume Examples & Samples
- Sound Knowledge in Antibiotic Test
- Be willing to work in a team-based environment
- Have solid math skills
- Be able to work with limited direct supervision
- Have good problem solving/organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
- Have excellent computer skills
- Have the ability to analyze data
- Be attentive to detail
- University degree in Microbiology, or related science
- A minimum of 3 years microbiology laboratory experience in pharmaceutical industry
- Sound knowledge of practical microbiological assays
- Sound understanding of USP, EP, BP, GMP, cGMP and ICH guidelines for microbiological analysis
- Computer proficiency with MS Office programs
132
Microbiologist Resume Examples & Samples
- Able to coordinate and motivate a team towards a common goal
- Able to maintain highest quality standard all the time
- Able to maintain good turnaround time (TAT) and on time delivery (OTD)
- Technical knowledge and experience in related field and in using quality management methods and tools
- Able to work independently and to coordinate several activities simultaneously
- Able to interact with all levels of management, suppliers and clients
- Good communication, negotiation and interpersonal skills
- Acts quickly and decisively; able to make tough calls
- Works well under pressure, challenges status quo
133
Microbiologist Resume Examples & Samples
- Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments
- Actively support new product development activities
- Participate in the development and improvement of the manufacturing processes for existing and new products
- May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ)
- Point of the contact for suppliers for new process development, quality issues and process improvements for assigned projects
- Support product transfer to other plants/facilities
- Participate in or lead continuous (breakthrough) improvement activity and process re-engineering projects
134
Microbiologist Resume Examples & Samples
- Execute and maintain the dose audit and bioburden testing program to support EO and radiation sterilization. Tracking and trending data as well initiating and writing investigations
- Ensure timely release of sterile products from contract sterilizers. Provide input on the resolution of sterility related non-conformances. Ensure records are maintained per company policy, as applicable
- Execute and maintain the environmental monitoring program for cleanrooms and utilities according to and meeting schedule. Tracking and trending data as well initiating and writing investigations
- Using excellent technical writing experience write procedures, protocols, final reports, deviations and investigations
- Submission and tracking of LAL samples, timely review and release of results. Provide input on the resolution of LAL related non-conformances including the writing of investigations
- Work with contract laboratories to ensure effective communication allowing for testing to be performed accurately and per Wright requirements
- Work with Operations and QA to identify and solve problems to ensure no stoppage in product release
- Put Biological Indicators on test and read to determine acceptable EO cycles
- Review and approve autoclave cycle documentation
- Support 5S initiatives for Sterility Assurance Work area
- Microbiology experience is required. Either industrial or clinical would be acceptable. Must know how to read plates, perform Gram stains, understand identifications and the types of organisms and impact to cleanrooms and product
- Must be able to review microbiological data to determine OOS, trends, and required next steps
- Be able to understand how microbiology impacts sterilization and support the Sterility Assurance Engineers as needed
- Understand clean rooms/zones (Class 5 – 8) and aseptic technique
- Must demonstrate initiative, have exceptional attention to detail, understand a sense of urgency, and be able to adjust to multiple and shifting priorities quickly
- Microbiologist position requires Bachelor's of Science degree in Microbiology, Medical Technology, or other Biological Science (with microbiology experience). Prefer minimum of 2 years of microbiology laboratory experience and experience with aseptic technique
135
Microbiologist Resume Examples & Samples
- He/ she is also required to work on projects assigned to him/ her by his/ her immediate supervisor and eventually able to provide recommendations in project attachments and lead/ coordinate activities in assigned projects
- To train/ coach Lab Analysts, and if required, other stakeholders
- He/ She may be required to perform laboratory testing when necessary. In addition, he/ she will be supervising a team of lab analyst/ technicians
136
Site Microbiologist Resume Examples & Samples
- Provide support to the site Sterility Assurance Group
- This role is responsible for assisting the sterility assurance specialist in setting the standards and systems for bio-burden and its control
- Ensuring that the bio-burden data is accurate and representative and that the process is adequately assessed and documented
- Ensuring that the Biological Indicator validation is accurate and fully compliant with the sterilization monograph and site procedures including proper storage, assessment, use and measurement of the BI’s used in the validation process
- Assessment/ approval of changes with regard to sterility assurance/ bioburden control systems in conjunction with the sterility assurance specialist
- Provide leadership and direction in all areas relating to the sterility assurance of the product
- Ensure clear communication to all stakeholders and customers
- Ensure systems are in place to such that all site microbiological activities are carried out in compliance with product license commitments, cGMP and Quality standards
- To lead all microbiological discussions during regulatory inspections and internal audits
- Anticipate and plan for future requirements within remit, including such aspects as procedural requirements, compliance requirements, efficiency developments and anticipated changes needed to reflect future demand for services from the departments
- Ensure safe practices are adhered to at all times in the laboratory
- Identify and support training needs required for the site and the QC team
- Ensure clear and measurable goals are set in a timely manner for both QC and BU teams
- To take the responsibility to engage employees to enable the delivery of the departments functional goals including financial and people development
- Provide support to, and deputize for, the QC Manager as required
- Provide support to the QC Management team as required
- Foster an environment of continuous improvement and providing leadership in this area by identifying and implementing practices to deliver efficiency, cost reduction, quality and service level improvements across the site
- Responsible for the QC Technical Support & Release Team
- Support the development of the deputy site microbiologist role and work with these personnel to develop and implement continuous improvement projects from a microbiological perspective
- Provide support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies and apply best practice in Microbiological techniques and systems
- To ensure that all company policies are adhered to by self
- Primary degree in Science essential supported by a sound technical background in Microbiology or equivalent knowledge and experience
- Proven years microbiology expertise in a regulated Pharmaceutical industry essential
- Excellent interpersonal and communication skills with good leadership abilities
- Experience of direct interaction with Regulatory Bodies (e.g. HPRA, FDA) desirable
137
Microbiologist Resume Examples & Samples
- Masters of Science (M Sc)
- 1- 3 years of relevant work experience
- Masters of Science (M Sc) in Microbiology
- IT skills (Microsoft words, Excel and Power point)
- Good presentation skills
- Providing analytical support to MLT Section
- Performing and manage assigned laboratory duties
- Perform MLT of raw materials, non-sterile bulk and finished products , bulk for filtration of sterile products
- Perform BET of products ,raw materials, WFI and Steam condensate
- Checking of Graph recorders of Sterilizers of Production and Micro Lab
- Ensure to perform tests according to GSK specification to meet the schedule
- Perform ATM validations for MLT of Products and prepare review reports
- Perform timely test registration on LIMS
- To perform fertility check of Media
- Assists in Compliance of Level I ,Level II and Level III Audits
- Performing tests and Documenting results GSK Standards. Checking of Air flow pattern and Air velocity of Micro Lab
- Any additional task assigned by the departmental manager/ Section Incharge
- Following EHS standards and guidelines, attend workshops and adhere to SOPs
- Compliance to corporate,HR/IT policies
138
Microbiologist Resume Examples & Samples
- Execute all lab methods per Good Laboratory Practices to test raw materials, in-process samples and finished goods for dietary supplement, foods and personal care products
- Aseptically sample products for microbial testing. Determine levels of microorganisms and ensure all products are free of harmful pathogens
- Perform other microbial tests, including: challenge testing to determine preservative efficacy, environmental monitoring, and probiotic testing
- Study the growth, structure, development and other characteristics of microorganisms
- Identify microorganisms by microscopic examination of physiological, morphological, and cultural characteristics
- Reports test results and processes to ensure conformance to laboratory and document/record control procedures
- Use of logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Identify complex problems and review related information to develop and evaluate options and implement solutions
- Control operations of equipment or systems daily. Assist in the calibration and verification of new and existing laboratory equipment
- Demonstrates aseptic techniques in sampling and conducting all microbial assays
- Familiar with official methods for microbial testing, including AOAC, USP, BAM, and others
- Familiar with pathogen verification/identification methods
- Bachelor's degree from a four-year college or university in Microbiology, Food Science, or related fields
- Lab work experience is a plus; or equivalent combination of education and experience
- Experience testing dietary supplements, foods and personal care products
- Rapid microbiology testing experience a plus
- Employee is frequently required to sit for extended periods of time and may be required to talk and listen to employees and/customers
- Employee is occasionally required to stand for long periods of time; walk; use hands to finger, handle, or feel; and reach with hands and arms
- Employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
139
Microbiologist Resume Examples & Samples
- Minimum of a Bachelor’s Degree is required in Chemistry, Biology, or related discipline and a minimum of three years of related experience
- Professional experience in sterilization technologies and biological indicators is preferred
- Professional experience analyzing functional compatibility of medical devices with sterilization processes is preferred
- Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment and with medical device manufacturing partners
- Strong, GDP-compliant documentation skills required
- Strong understanding of compliance with applicable laboratory and safety procedures is preferred
- A strong working knowledge of QSR, FDA / ISO guidelines is preferred
- This position is located in Irvine, CA and will require up to 10% domestic travel
140
Microbiologist Resume Examples & Samples
- Ensure that the relevant Internal Control Plans are executed for equipment and reagents
- Experienced and competent in performing Microbiological analysis of finished products, line samples, environmental samples and raw materials
- Conduct microbiological second examinations as required
- Ensure that microbiological results are captured in SAP timeously to ensure on time release of products
- Comply with all laboratory safety requirements and factory rules
- Have sound knowledge on GLP requirements
- Ensure that all samples for external analysis are prepared and send as per requirements
- Participation in proficiency Testing
- Line Inspections and releases after cleaning
- Develop and communicate microbial trends report
141
Microbiologist Resume Examples & Samples
- Collects samples
- Prepares standard and sample solutions
- Maintains appropriate records
142
Microbiologist Resume Examples & Samples
- This testing of samples may involve collecting samples in various production areas
- Prepares solutions, suspensions and media to perform essential laboratory procedures
- Performs clerical and administrative duties using established systems to gather information needed to define test requirements and communicate results to laboratory customers
- Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation. Keeps supervisor informed of work status
- Prioritizes workload and meets scheduled timelines
- Communicates/maintains equipment and supply needs required to avoid delays in testing
- Reports results of assignments and maintains and performs related record keeping in compliance with approved regulatory policies and standards to meet quality and accuracy requirements. Follows and complies with all appropriate operations and testing procedures, GMPs and safety and health requirements as applicable
- Demonstrates good housekeeping practices to minimize data mix ups, potential laboratory contamination and safety hazards. Understanding and handling of bio- hazardous materials and waste using proper and safe techniques
- Basic verbal and written communication skills
- Adaptability/cooperation
- Exhibit positive attitude regarding work and responsibilities
- Ability to work collaboratively within teams
- Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
- Continuously look for ways to do things faster and better, while maintaining high quality standards
- Is creative and intellectually curious; tries different and novel ways to solve obstacles
143
Site Assistant Microbiologist Resume Examples & Samples
- The Assistant Microbiologist will be the deputy to the Site Microbiologist
- The Assistant Microbiologist will assist the Site Microbiologist in the development and implementation of the site’s microbiological program and help to ensure overall compliance of the site vs the relevant microbiological standards
- Specifically you will assist the Site Microbiologist to ensure compliance in the following areas
- The individual must possess a sound technical understanding of microbiology and its application to industrial processes, operating standards and product
- The ideal candidate will have a degree in microbiology or a related subject and ideally a minimum of 2 years experience in industrial microbiology
- The Site Assistant Microbiologist must be an influential leader to make sure the required actions are taken . The individual must have leadership, ability and authority to be capable of implementing change where needed
144
Microbiologist Resume Examples & Samples
- Provide microbiological support for the Oral Microbiology programme
- Ability to work independently under the guidance of senior team member
- Ability to learn, adapt and develop current methodologies where appropriate, demonstrating an ability to problem solve and ideate creative solutions and opportunities
- A passion for new science and a desire continually learn and to help move forward both themselves and the wider team
- Show scientific integrity and follow safe working practices
- Good working knowledge and experience of using Microsoft Office programs (Word, Excel, PowerPoint and Outlook)
- Ability to conduct scientific searches and basic statistical analysis
- Preferred experience of innovation in home and personal care products
145
Microbiologist Resume Examples & Samples
- Lead the experimental design and evaluation of new preservation technologies across HPC to ensure products of the future are safe by design from a formulation/preservation and processing perspective, working as part of multi-disciplinary project team
- Develop/Implement both new and existing molecular methods
- Design and perform practical work to evaluate preservative efficacy
- Report and make recommendations on new technical opportunities to stakeholders
- Working with external preservative suppliers and external test institutes
- Liaise with preservative suppliers to develop partnership programmes
- Maintaining strong links and developing networks across multi-disciplinary project teams
- Microbiological Science background at PhD level in industrial microbiology with proven applied industrial microbiology experience in a related industry. MSc or BSc will be considered with relevant experience
- Proven science and technology experience in applied microbiology, particularly in molecular microbiological techniques. Knowledge of microbiomics and machine learning to a level to be able to discuss ideas with leading edge experts
- Experienced in the creation, development and implementation of ideas related to microbiology
- Ability to write scientific papers and reports
- The candidate will be expected to quickly develop a working knowledge on predictive modelling techniques and large data set analysis
- Proven practical microbiological skills,
- Proven experimental design capability
- Excellent IT/Information Technology awareness
- Experience in working with external partners
146
Process Microbiologist Resume Examples & Samples
- Degree in Biology / Microbiology or equivalent qualification and experience
- Previous Experience in a GMP environment (Pharmaceutical / Food industries preferred) ideally Aseptic processing, sterilisation processes, validation or Quality Assurance
- Knowledge of GMP and regulatory requirements for Sterile / Aseptic operations
- Experience / Qualifications in Lean or Continuous Improvement would be highly desirable
- Experience and Knowledge of Root Cause Analysis (RCA) / FMEA
- Strong knowledge of manufacturing processes and human performance is also highly desirable
- Excellent verbal and written communication and presentation skills
- Knowledge and experience of systems live CDMS or SAP is highly desirable
- Able to work independently or part of a larger team
- Assessing the impact of under-performing and/or failures of processes and systems and prioritising corrective actions to enhance performance
- Build sterile manufacturing capability for the organisation through detailed subject matter knowledge, establishing and implementing best practise
- Be able to review current practises and challenge the status quo to drive change
- Leading change control for implementation of new components, equipment, processes etc
- Work closely with the Operational teams to resolve problems. This may involve periods of out of hours work to provide the necessary support required to implement change
- Delivery and documentation of training relevant to area of responsibility
- Providing technical expertise to maintain aseptic manufacturing processes in a manner complaint with GMP (Good Manufacturing Practice) and safety standards and represent area of responsibility in internal and external audits
147
Microbiologist Resume Examples & Samples
- Hands-on experience with microbiological safety Level 2 precautions
- Demonstrated analytical and critical thinking abilities
- Experience with ERP system – SAP or similar a plus
- Must have personal accountability for results and integrity
- BS/BA in Biology, Cell Biology, Micro Biology, Biochemistry or equivalent years of work experience in related field
148
Microbiologist Postdoctoral Fellow Resume Examples & Samples
- Assist other researchers in the laboratory
- PhD granted within the last three years in Microbiology, Molecular Biology, Synthetic Biology, or a related discipline whose focus is the molecular biology and physiology of bacteria
- An imaginative and rigorous approach to research and the ability to communicate with scientists in other disciplines
- Expertise in bacterial strain construction and cultivation
- Experience training or assisting other researchers
- Experience working in a multi-disciplinary environment
149
Microbiologist Resume Examples & Samples
- Ability to perform key routine tasks i.e. bioburden testing, environmental monitoring, sterility testing, GPQ testing etc
- Develop and author protocols and new procedures and to revise existing procedures to comply with requirements
- Timely completion of documentation and data entry for routine test procedures
- Assist in laboratory investigations such as out of specification (OOS) results for routine samples as well as sterility failures. Ensure compliant and timely reporting and investigation close-out
- Support development and improvement of laboratory processes and systems. Support Continuous Improvements projects
- Execute validation studies for laboratory processes, where applicable
- Ensure compliance to Good Manufacturing Practices and Good Laboratory Practices
- Perform periodic micro data analysis and trending of data
- Ensure the lab work environment is free of any recognized hazards and comply with all safety regulations/laws
- Ensure regulatory inspection and customer audit readiness
150
Microbiologist Resume Examples & Samples
- Knowledge and understanding of Stop Orders, Concessions, ESD, Calibration, Preventative Maintenance, Material Identification & Segregation, documentation configuration control practices; documentation & disposition of non-conforming material, and Good Documentation Practices requirements, as associated with this job type/position
- Associate degree plus 2 years working experience in Manufacturing or Laboratory or Bachelor’s degree
- Ability to speak, understand, read, and write in local language
- Proficient with software applications applicable to the job
- Must be available for nights and weekends as needed
- Must have the ability to distinguish color
- Ability to lift 25lbs
- Aseptic Technique Experience
- Microbiology bachelor’s degree
- Cleanroom experience
- VITEK experience
- Experience with LAL Gel-clot testing
- Membrane filtration sterility testing experience
151
Microbiologist Resume Examples & Samples
- Include the following. Other duties may be assigned
- Performs routine microbiological testing of products and raw materials according to SOPs and Methods
- Documents routine procedures following laboratory and company guidelines
- Reviews and approves work performed by technician and peers
- Prepares media for validation procedures
- Develops and validates microbiological test methods for sterility testing, bacterial endotoxin testing, antimicrobial effectiveness testing, and bioburden testing
- Perform filter validation studies including Bacterial Retention Testing
- Performs antibiotic assays per appropriate USP method
- Read and interpret product labeling instructions (package inserts) in reference to appropriate dosage and administration guidelines
- Prepare protocols and execute testing for Microbiological in use stability studies on drug products under development
- Coordinates and tracks Microbiological testing necessary for ANDA submissions and prepares reports for submissions including Microbiological Product Development Reports, Antimicrobial Effectiveness Testing Reports, and Bacterial Retention Reports
- Approves product specification for release in management absence
- Prepare and review protocols in support new product development
- Assist on the generation of outside source information retrieval and-evaluation in support of special project work
- Bachelor's degree (B.S.) from four-year college or university with Major in Microbiology and two to three years related experience and/or training
- Or MS degree and one year Pharmaceutical experience
152
Microbiologist Resume Examples & Samples
- Performs routine microbiological testing of products, raw materials, components and controlled environments according to site Standard Operating Procedures and compendial methods
- Knowledge of or experience in the following
- Method Suitability and routine
- Sterility Testing by Membrane Filtration and Direct Inoculation
- Microbial Limit Testing (formulated product, raw materials and packaging components)
- Antimicrobial Effectiveness Testing
- Antibiotic Microbial Assays for Potency Determination
- Bacterial Endotoxin Testing
- Environmental Monitoring of controlled, classified areas including the use of Contact Plates, Settling Plates, and Air Samplers
- Total Heterotrophic Plate Count of potable and Process Water
- Preparation, Sterilization, Incubation, and Growth Promotion of culture media
- Disinfectants and lethality studies
- Population Determination and Testing of Biological Indicators; operation of autoclaves
- Identification of microbial organisms
- Assists in non-conformance investigations including deviations, and OOT/OOS related to product results and environmental monitoring results
- Issues and revises GMP documents such as SOP’s, protocols/reports, testing monographs, data sheets, etc
153
Microbiologist Resume Examples & Samples
- Domestic 10% International 15%
- Travel, transportation, and moving expenses will be paid: May be authorized
- Recruitment Incentive: No
- Research position: No
- Promotion potential: No
- To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process
- Fax your documents to1-478-757-3144
- Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed
- A complete Assessment Questionnaire
- Other supporting documents
- SF-50 (if you are a federal employee or have reinstatement rights as a federal employee or Current or Former Political Appointee)
154
Microbiologist Resume Examples & Samples
- E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing
- Pre-employment physical required: No
- Immunization required: No
- Finally, you will be transferred to FDA's USA Staffing system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided by USA Staffing and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS
- If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications"
- You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button
- You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's USA Staffing system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step
- Knowledge of a wide variety of concepts, principles, practices and methods applicable to microbiology and/or related biological sciences such as biochemistry or physiology
- Ability to analyze/interpret scientific data
- Ability to communicate in writing
155
Microbiologist Resume Examples & Samples
- Knowledge of advanced principles, concepts, practices, standards and regulations relating to microbiology and/or related biological sciences such as biochemistry or physiology
- Ability to provide leaderships skills
- Ability to communicate orally
156
Assistant Microbiologist Resume Examples & Samples
- Product testing
- Environmental testing
- Raw ingredient testing
- Housekeeping
- Media preparation/general lab work
- To all testing in the lab through instruction via manuals and through training
- Problem solving is required when test results are out-of-specification to assign a cause and rule lab error
- Impact of actions: Depending on error, there would be an explanation on a deviation report or voluntary/FDA for a major error
157
Microbiologist Resume Examples & Samples
- Install lab equipment, performs qualification and validation activities of lab equipment following written protocols
- Conduct and validate necessary test methods or compendia methods in the lab and performs routine testing and documentation
- Participate in laboratory investigations
- Recommend solutions to optimize test procedures to improve overall efficiency
- Facilitate health authorities’ inspections and internal audits within area of work
158
Microbiologist, Quality Resume Examples & Samples
- Be the on-site technical expert for microbiology laboratory testing including bioburden testing, pyrogen testing, and other required routine/non-routine testing for medical device manufacturing
- Lead, mentor, and train microbiology laboratory technicians on laboratory testing requirements for routine/non-routine testing
- Perform critical records documentation and review and participate in documentation preparation and assistance for regulatory audit review. Review and approve laboratory testing data, escalates issues to management
- Performs root cause investigations and implement correction/corrective actions for laboratory related excursions, with minimal supervision
- Lead special projects as assigned to completion with minimal supervision, developing technically sound protocols and reports and participating in execution of validations/revalidation work
- Utilize communication skills as an important member of audits, and for participation in team / global goals; apply judgment, support development projects, problem-solving leadership, impact evaluation, and apply regulatory compliance standards
- Be part of a dynamic team environment, and Edwards life-saving values, where we also focus on employee engagement
- Knowledge of and experience with microbiology laboratory testing for medical device company is strongly preferred
- Excellent communication skills, both verbal and written, and interpersonal skills to effectively interact with and contribute constructively to team environment/outside departments
- Previous experience working with and understanding requirements for microbiology laboratory testing and knowledge of relevant ISO standards is strongly preferred
- Strong project management skills and strong leadership skills are required
159
Associate Microbiologist Resume Examples & Samples
- Use of proper handling procedures and aseptic technique
- Prepare composites of routine samples
- Perform initial dilutions and enrichments of samples
- Perform sample plating for quantification
- Perform transfers
- Perform instrumentation work with guidance as needed
- Perform diagnostics and reporting work with guidance as needed
- Perform project work with guidance as needed
- Perform routine cleaning and quality checks for equipment
- Perform routine cleaning of work areas
- Media preparation and quality control, including all appropriate documentation
- Autoclave operation
- Document work and maintain laboratory records
- Contributes to a cohesive team environment
- 0 – 2 years
160
Microbiologist Resume Examples & Samples
- isolation of DNA from tissue and body fluids/samples
- use of PCR in identification of microbial agents
- DNA sequencing and sequence analysis
161
Microbiologist Resume Examples & Samples
- Under the direction of a more senior staff member, carries out research on assigned research problems contributing to the attainment of a defined research objective
- The nature of the work performed by the incumbent will normally be the solution of specific aspects of complex research problems
- The problems assigned are normally short range in terms of time required for solution
- Bachelors Degree required. Successful performance requires a sound basic knowledge of the individual scientific discipline and the ability to apply fundamental principles and techniques to the problems assigned,
- Skilled in cell cultures, fermentation, bacterial and virus production; aseptic techniques and basic methods of virus propagation and titration
- Skilled in virus titration, SDS PAGE, Western blots and ELISA methods
162
Clinical Microbiologist Resume Examples & Samples
- Team member or lead involved with implementating process improvements and help to implement process improvements and or corrective actions resulting from these failure investigations
- B. S. degree in a microbiology, chemistry, medical technology, or biochemistry or related field is desired
- 1-3 years of relevant clinical microbiology experience
163
Microbiologist Resume Examples & Samples
- Main Responsibility
- Execution of studies for evaluation/implementation of Rapid Microbiology Technology
- Execution of routine compendial Microbiology methods for Pharmaceutical and Biological programs (Testing includes: Microbial Examination testing, Bioburden, Antimicrobial Effectiveness, Sterility, Endotoxin)
- Assistance with special studies (Ex: Microbial risk assessments, hold time evaluations)
- Execution of method validations of products/API’s/raw materials in compendial test methods
- Agar plate reading (bacteria/yeast/mold)
- Documents testing/results into Electronic Laboratory Notebook system and reports results in LIMS system
- Perform temperature monitoring of incubators, refrigerators, and freezers
- Perform decontamination tasks of class A cleanroom
- Preparation/maintenance of microbial stock cultures
- General lab tasks: includes organizing supplies/media, routine Gram staining, removal of Biohazardous waste, etc
- At least six months related laboratory experience including aseptic skills
- Basic knowledge of Rapid Microbiology Technologies
- General laboratory skills, and experience with pipettes
- E xperience using formulas and linking spreadsheets in Excel
- Attentiveness to detail and good GMP documentation practices
- Bachelor's degree in Chemistry, biology, or related science
- Ability to work weekends or off shift hours as needed
164
Microbiologist Resume Examples & Samples
- Execute 1 to 3 worklists on average per day
- Attend Prioritization meetings to support assay transfer, co-validation, qualification and batch production release/stability testing for demonstration, engineering, clinical trial, process validation and/or commercial manufacturing in a GMP environment as needed
- Responsible for becoming proficient in a breadth of methodologies including but not limited to compendial test methods, raw material test methods, electrophoresis, spectrophotometric, compendial test methods, endotoxin, bioburden, microbial identification technologies, ELISA, purity/gram stain and viability and residual component determination methods
- Responsible for working effectively with electronic, as well as paper based systems including LIMS and data acquisition systems including but not limited to Empower
- Execute test methods, tabulate data and provide data interpretation
- Troubleshooting in support of investigative testing may be required
- Assist in revision of test methods, LIMS builds and creation of training materials as necessary
- Ability to work in a fast paced team-oriented setting and possess good communication skills
- Knowledge of cGMP
- Assay transfer experience
- Knowledge of LIMS
- Experience executing test methods in the biotech or pharmaceutical industry
- Bachelor's degree in life sciences, biology, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
165
Microbiologist Resume Examples & Samples
- Performing analyses for pharmaceutical microbiology (routine and non-routine); reviewing and evaluating raw data for acceptability
- Setting up and validating new analytical or related processes used by the department
- Performing collection of water/EM samples when required
- Perform routine and non-routine microbiological analyses or related procedures (including those performed in controlled access areas); record and document data according to regulatory requirements
- Travel to client facilities (including overnight stays, if required) to collect EM/water samples according to approved procedures and protocols; package, ship, or transport samples back to laboratory for analysis
- Perform special gowning and applicable safety procedures as required (when working in clean rooms, rooms containing hazardous materials or areas requiring use of respirators or other specialized protective equipment) when performing EM/water collection functions
- Act as Principal Investigator for GLP studies as needed
- Technical and reasoning skills, including logical thinking and deductive reasoning
- Willingness to follow instructions and comply with company policies
- Bachelor's degree in Microbiology, biology, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- At least one year laboratory experience
166
Microbiologist Resume Examples & Samples
- Execution of QC environmental & utility sampling
- Performs utility (water) monitoring
- Understanding of basic biological science principles
- Ability to multi-task and coordinate multiple activities in parallel
- B.S. degree (biological science preferred) or A.S. degree (biological science preferred)
- 0-2 years of relevant experience (B.S. degree) or 8+ years of relevant experience (A.S. degree)
167
Senior Microbiologist Group Leader Resume Examples & Samples
- Performs environmental monitoring
- Maintains supplies, performs laboratory housekeeping, maintains current training, collaborates with client FTEs
- Executing these responsibilities in a cGMP manner
- Supervise on-site PSS group
- Develop and track performance metrics
- Act as primary point of contact for our client
- Demonstrated technical ability regarding fundamental sampling techniques
- Developing or demonstrated instrument/method troubleshooting and problem solving skills
- General knowledge of FDA/EMEA regulations and compliance
- Ability to provide weekend coverage
- 2 years of relevant experience (B.S. degree) or 8+ years of relevant experience (A.S. degree)
168
Senior Microbiologist Resume Examples & Samples
- B.S. degree in a science field
- 5 years experience in a GxP regulated laboratory environment
- MS. degree in a science field
- Knowledge of environmental testing
- Expert and knowledgeable in cGMPs and other regulations in order to assure laboratory compliance
- Leads and documents investigations according to established procedures and recommends corrective actions. Ability to use root cause analysis. Initiate and complete CAPAs and change controls
- Must have good technical writing skills and high attention to detail
- Ability to train staff and oversee testing operations by lower level analysts within the laboratory
- Perform calibrations and some troubleshooting of lab instrumentation
- Microbiological SME for internal and external regulatory inspections and audits
- Strong collaboration skills with lean Laboratory knowledge and experience
- Write and execute new microbiological methods
- Assist with the execution of validation protocols and reports, write analytical procedure SOPs and equipment SOPs
- Perform routine testing while following validated procedures for raw materials, in process samples, facility / environmental monitoring, bulk-drug substance release and stability testing. Report clear and defensible assay results
- Review and approve all microbiological test results for environmental monitoring, raw materials, growth promotion, utilities and In process samples
- Good working knowledge of Microsoft Excel, Word
- Ability to prioritize and organize tasks
- Strong verbal and written communication skills
169
Sterilization Microbiologist Resume Examples & Samples
- Minimum of 1 year of combined work experience in Quality, Technical, Manufacturing, and/or Laboratory environment
- Bachelor’s degree or higher in Microbiology, Biology, Chemistry, Chemical Engineering, or BioMedical Engineering, or related discipline from an accredited institution
- Experience with and complete understanding of ISO 11135, ISO 11137, ISO 10993-7 and 11737 international sterilization and microbiological standards for medical devices
- Experience with Ethylene Oxide (EO) and Gamma Irradiation sterilization technologies
- Experience working with quality systems applied to health care industry: ISO 13485 and FDA QSR for medical devices, cGMP for drug products
170
Microbiologist Resume Examples & Samples
- Minimum BS degree in a relevant scientific discipline
- Minimum 2 years’ experience in a pharmaceutical or comparable environment
- Familiarity with Drug cGMP, GLP and GMP regulations
- Demonstrate ability to communicate effectively in a team environment
- Proficient with laboratory computer software
- Demonstrate flexibility in carrying out a variety of assignments in a high-quality work environment
- Ability to complete assigned task with minimum supervision
- Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings
- Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information
- Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed
- Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity
- Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality
- The work environment is representative of a group laboratory environment
- While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision
171
Microbiologist Resume Examples & Samples
- Work with QA team to develop and implement process control initiatives
- Perform equipment evaluations, maintenance, and calibrations (ICPs)
- Work with other departments in leading/teaching/educating EE’s in GMPs and HACCP
- Assist with weekend and holiday coverage as needed
- Maintain safe work environment and support safety programs
- Monitor incoming raw materials and maintain traceability program
- Review and approve daily paperwork for all lines, including follow-up w/ resources for missing documentation
- Support warehouse and production with product holds, records, dispositions and root cause analysis
- Assist with consumer complaint processing, reporting, and analysis for all aspects of the plant
- Assist with all plant Quality initiatives and projects as needed
- Perform microbiological testing on in-process, finished product and spring samples
- Perform hygiene audits for all departments and assist resources with corrective actions
- Conduct chromatographic and spectroscopic analysis for bromate and acetaldehyde
172
Microbiologist Resume Examples & Samples
- Serve as silicone emulsions microbial expert for the business
- Maintain and advance key control strategies and capabilities focusing on fundamental, data driven microbial science
- Develop proactive microbial risk mitigation strategies in conjunction with the GMP process expert(s)
- Evaluate and integrate best practices related to microbial risk during the product development process
- Establish and leverage external linkages to maintain best in class practices for microbial control
- Perform efficient/reliable microbial testing in accordance with regulatory or customer guidelines (including microbial challenge testing, water analysis, chemical water analysis, environmental monitoring, raw materials and finished goods)
- Drive technical and fundamental microbial science understanding, best practices, and continuous improvement regarding controls and testing capabilities through global standardization
- Work with production facilities to provide support for microbial root cause investigations through data monitoring and analysis
- Support production transfers utilizing a risk based approach
- Responsible for identifying appropriate tests and conducting, reviewing, and verifying routine microbial testing results
- Provide suitable preservative recommendations throughout product development life cycle
- Provide technical assistance for troubleshooting of customer issues
- Support upgrades to the corporate microbiological control program for emulsions across all key areas
- The Dow Chemical Company does not offer relocation if the position is offered to someone who lives outside the area or reimbursement for travel to and from interviews. If you consider a position that is not within the area you reside you will be responsible for all cost that incur.**
- Proficiency in Microsoft applications, such as Word and Excel, and have the ability to learn new systems quickly
- A fundamental understanding of the concepts and theories around microbiology and the ability to translate microbial technical concepts to all levels of the organization as well as external customers
- Excellent communication, teamwork and influencing skills and the ability to articulate the science through the entire product life cycle
- Must be able to read, write, and speak English
- Must be able to willing and able to work in such environments wearing safety equipment, such as respirators, earplugs, goggles, and steel-toed shoes
- Must be able to willing and able to work in such environments with frequent bending, reaching, and lifting
- Must be willing and able to stand or walk for extended periods of time
- 3 to 5 years in a cosmetic/beauty care GMP manufacturing environment and Food or Pharmaceutical GMP experience would be preferred
- Experience with rapid micro identification principles such as MALDI-TOF or phenotypic characterization and laboratory information systems such as LIMS is desired
- Understanding of US and European Cosmetic, Food, and Industrial Product regulatory requirements and guidelines is preferred
173
Lead Microbiologist, ZP Resume Examples & Samples
- Payment of relocation expenses is not authorized
- Payment of recruitment incentives is authorized
- Selected applicants may qualify for credit toward annual leave accrual based on prior non-federal work experience or uniformed service experience
- This position is not in the bargaining unit
- Your application materials must clearly demonstrate this experience. Failure to do so will result in your application being marked as ineligible
- Overseeing lab functions for staff performing analysis of food products and bi-products and microbiological and biochemical hazards using traditional microbiological methods and molecular analytical techniques
- Reviewing lab processes to ensure that proper microbiological lab processes are followed; ensure results meet lab standards and to recommend improvements; and
- Ensuring the lab is current on microbiological methods for food safety and lab staff is properly trained to ensure quality work products
174
Microbiologist Resume Examples & Samples
- 1) Performs microbiological testing on water, bulk pharmaceutical chemicals and drug products
- 2) Collects samples
- 3) Prepares standard and sample solutions
- 4) Maintains appropriate records
175
Microbiologist Resume Examples & Samples
- Identifies bacteria and susceptibilities, molds, yeast, parasites, and other organisms
- Performs clinical laboratory procedures, examinations and other tests
- Routine Testing, Proficiency Testing and Data Review
- Support for other departments validation and operations as needed
- Develop, review and revise laboratory Standard Operating Procedures
- Train laboratory personnel on Microbiological test methods
- Write study protocols, reports, test procedures, etc
- Develop/validate Microbiological test methods for cell therapy product, raw material and release testing
- Perform protocol driven studies for B/F, bioburden, endotoxin, sterility testing, EM, ID, etc
- Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices (GDP)
176
Microbiologist Resume Examples & Samples
- Determine microbial content and identify microorganisms from products, raw materials and components. Interpret test results and provide disposition/recommendations
- Responsible for microbiological quality of the D.I. water system through routine sampling and testing. Evaluates results and recommends corrective actions when required
- Monitors the plant’s environment, identifying potential problem areas. Recommends and assists in implementing effective corrective measures
- Monitors the effectiveness of cleaning and sanitizing procedures, recommends appropriate changes in conjunction with Operations and Corporate Microbiology which improves cleaning/sanitation and prevents contamination
- Perform internal laboratory and facility GMP audits as required assuring compliance with Corporate and Federal Regulations
- Performs all necessary cleaning and sanitization validation studies for new products and new equipment
- Provide guidance concerning equipment cleaning and sanitizing procedures
- Develop protocols for investigational projects
- Maintain records of all tests performed, methods used and final disposition according to Standard Operating Procedures
- Assist in preparing media, reagents and materials as needed for laboratory testing
- Maintain departmental stock cultures
- Coordinate laboratory purchases and maintain equipment service contracts
- Assist in developing programs to educate personnel in GMP/GLP procedures
177
IVC Microbiologist Resume Examples & Samples
- B.Sc. Microbiology, Biochemistry, or related science required
- Must be an accredited Microbiologist
- 5 years of experience in microbiology laboratory required
- Competent in commonly used microbiological concepts, practices, and procedures
- Competent in the use of Microsoft Office
178
Microbiologist EM Sampler Resume Examples & Samples
- Environmental and process monitoring in Grade A, B, C, and D environments
- Oversight and routine EM during media fill process
- Read plates/review data
- Use electronic document management systems (Atlas) and LIMS (Labware)
- At least 6 months of related laboratory experience
- Prior experience in the performance of passive/active air, surface, and water sampling as well as process monitoring
- Experience with aseptic technique (prior gowning qualification a plus)
- Experience working in a team environment, adaptability, self-motivation, and a positive attitude
- High attention to detail and adherence to safety protocols
- Basic laboratory skills and knowledge of laboratory practices/procedures
179
QC Microbiologist Resume Examples & Samples
- Driving method development / verification and validation of Microbiological methods with sister site for the introduction of New Products
- Writing and Management of Protocols and Reports associated with the introduction of new methods example Bioburden and Endotoxin qualifications
- Provide Microbiological technical expertise to the QC team with respect to method and equipment troubleshooting and compliance activities
- Provide technical mentoring and feedback to the team. Sharing technical knowledge to ensure continuous improvement, technical development and promoting best practices, with particular emphasis on Microbiology
- Review and approve documentation on behalf of QC such as standard operating procedures, training modules, protocols, reports and Trackwise
- Management and communication of QC metrics such as Site routine metrics, Safety and compliance expectations
- Liaise and support Site Microbiologist when required
- Ensure compliance to GxP, safety and environmental standards
- Provide QC support for site plans, protocol executions, and summary reports
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Lead and implement initiatives that add value to QC Operations
180
Senior Microbiologist Resume Examples & Samples
- Basic understanding of principals of instrumentation, operations, methods, etc
- Follow methods and SOP’s and understand the scientific principles being applied
- Learn and be qualified on routine tests
- Once trained, perform routine analyses, including routine maintenance and calibration of instruments with minimal supervision
- Recognize problems and work with leader to resolve matters
- Document all work accurately, clearly and correctly, and in compliance with regulatory requirements
- Enter, calculate, review, evaluate, and verify data, as required
- Assist with the preparation of written reports
- Assist more senior levels as needed in larger projects or tests
- Learn, understand, and work within the Eurofins Lancaster Laboratories IT systems and processes
- Perform laboratory work on weekends and holidays on a rotating basis with other members of the department
- Perform destruct runs
- Environmental monitoring, cleanroom, and medical device testing experience
- Bachelor's degree in Microbiology, Biology, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- 5 years experience in a microbiology laboratory
181
Microbiologist Resume Examples & Samples
- Bachelor (4 yr College) degree in microbiology or High School Diploma/GED with 7 or more yrs of demonstrated experience in a GMP microbiology lab
- Proficiency with computer systems including Microsoft Office products, LIMS (list other lab systems), etc
- Ability to working in a lab environment including wearing appropriate PPE and other safety required equipment and considerations
- Demonstrated strong math and documentation skills
- Demonstrated strong oral and written communication and interpersonal interaction skills
182
Microbiologist Resume Examples & Samples
- Identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of medical devices
- Practice two or more of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat
- Review biocompatibility tests and interpret the associated industry guidelines. Work with operations and research groups to develop new products and support continuous quality improvement initiatives
- Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments
- Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects
183
Supervisory Microbiologist Resume Examples & Samples
- E-Verify: If you are selected for this position, the documentation you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the E-Verify System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant
- Pre-employment physical required:No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- A background investigation may be required
- Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc
- Financial Disclosure Statement required: NO
184
Microbiologist Resume Examples & Samples
- Testing of samples such as raw materials and manufacturing products
- Prepares solutions, suspensions and media to perform essential laboratory procedures using aseptic techniques
- Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation
- Reports results of assignments, maintains and performs related record keeping in compliance with approved regulatory policies and standards to meet quality and accuracy requirements
- Demonstrates good housekeeping practices to minimize data mix ups, potential laboratory contamination and safety hazards
- Follows and complies with all appropriate operations and testing procedures, GMPs and safety and health requirements as applicable
- 1-3 years of experience preparing solutions, suspensions and media to perform essential laboratory procedures
- Bachelor’s Degree of Science preferably Biology, Microbiology, Medical Technology and Food Science or other closely related discipline with extensive significant experience can be considered in lieu of a Bachelor’s degree
- Must have experience working with non-sterile products, utilizing aseptic techniques and knowledge of proper laboratory safety procedures
- Adaptability/cooperation; Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
- High level of attention to detail
- Continuously look for ways to be more efficient, while maintaining high quality standards
185
Microbiologist Resume Examples & Samples
- Deliver true, accurate results in a timely manner
- Skilled expertise and diligence in using aseptic technique
- Technical knowledge and expertise in the use of molecular biology instrumentation for qualitative assays, and phenotypic techniques for quantitative assays
- Skilled in sample preparation, homogenization and serial dilutions
- Maintains documentation of microbiological results and testing traceability in the Laboratory Information Management System (LIMS)
- When appropriate, help to write/create documents for, and always follow laboratory quality management systems ISO 17025 m Mars Global Laboratory Quality Management System
- Work as a team player including open and honest communication, respecting confidentiality with any laboratory information
- Product Quality Custodian
- Masters the key scientific principles associated with Microbiological assays
- Understanding of microbiological testing techniques including FDA BAM testing methodologies
- Demonstrates knowledge and understanding of laboratory safety, chemicals
- Management and chemical hygiene plans
- Demonstrated experience and skill with Spreadsheet software (MS Excel preferred), Word, ELN, and Laboratory Information Management Systems (LIMS)
- Excellent organizational skills to adapt to fluctuating workloads while maintaining attention to detail
- Excellent interpersonal skills and the ability to work independently or as a member of a team
- Flexibility to changing priorities and timelines
- Bachelor’s degree in microbiology or related science (natural or food sciences)
- 2 or more years’ experience with microbiological analyses in food or related industries (advanced education may partially substitute for required experience)
- Experience working in a production lab environment
- Working knowledge of ISO 17025 standard
- Experience with LIMS and ELN
186
Microbiologist Resume Examples & Samples
- Candidate must demonstrate strong technical understand of methodology and systems of quality testing, scientific principles and practices. Specific duties for the position to include microbiological testing, providing input for projects, training of other employees, knowledge of laboratory and manufacturing systems, troubleshooting, document maintenance, environmental monitoring, media production and growth promotion, water testing, raw material testing, microbial identification and other duties as required
- Provide daily microbiological testing support under little supervision
- Collaborate with senior and associate members of group on method development and validation projects
- Provide training of other employees on technical, cGMP, safety and administrative aspects of job
- Support creation, revision and maintenance of documents including SOPs, methods, protocols and reports
- Carry out sampling/testing of purified and potable water systems using aseptic techniques
- Perform environmental monitoring of manufacturing and support areas using SAS volumetric and contact plate test applications
- Drive production of microbiological media including materials autoclaving, broth/agar medium production, nutritional adequacy/growth promotion culturing, pH assessment and inventory management
- Execute TOC, conductivity and microbiology assessments of water systems, employing on-line and manual methodologies, Standard Methods membrane filtration and colony enumeration
- Perform Microbial Limits Testing of raw materials and products per USP methodology including total aerobic/yeasts and molds quantitative methodology and qualitative organism presence/absence tests and perform preparatory testing/suitability of the test method
- Carry out identification of microbial isolates via traditional staining and culturing techniques and Vitek ID systems
- Drive input for continuous improvement activities (LEAN, SS) through participation intra-and interdepartmentally
187
Microbiologist Resume Examples & Samples
- Minimum of 2 years experience of routinely processing a variety micro samples including release testing, and environmental monitoring with minimal supervision in a cGMP Pharmaceutical setting
- Prefer experience with root cause analysis as it relates to microbiological issues
- Experience with Rapid Micro testing techniques, equipment and method validation is a plus
- Ensure quality and compliance in accordance with established procedures and standards of the Quality System
- Comply with and support the GSK Environmental, Health and Safety policies and procedures
- Accurately perform microbiological testing for raw materials, finished products, stability samples, environmental monitoring samples, validation samples and all other micro related samples according to prescribed methods in order to comply with required government, corporate, and site regulations
- Write, review, and update Microbiology SOPs, methods, and Quality Control Specifications in accordance with cGMP and USP guidance
- Perform microbial characterization and identification of microbial results
- Work in partnership with other Microbiologists in Consumer Healthcare and act as a member of the Microbiological Functional Group
- Analyze and trend environmental and water data and alert management of any trends potentially affecting product quality
- Make and test, microbial growth media and reagents. Maintain and calibrate laboratory instruments
- Develop microbiological methods, when needed, including conversion to rapid methods when feasible
- Maintain inventory and cleanliness of laboratory and supplies
188
Microbiologist Resume Examples & Samples
- A Bachelor's degree with advanced courses in Bacteriology, Chemistry, and/or other biological fields which shows knowledge of microbiology theory, principles, and practices and laboratory procedures, equipment, and instruments
- Ability to adapt to changing workload and analytical procedures as dictated by staffing and sample prioritization
- Supports actions related to seeking and maintaining ISO17025 laboratory accreditation
- Must be able to be certified under governmental laboratory accreditation programs such as FDA Dairy and Shellfish programs and third party auditors such as A2LA
- A copy of your DD214/DD215 form; OR a letter from the US Dept. of Veteran's Affairs indicating you receive a non-service connected pension; AND a copy of your veteran's disability letter from the Dept. of Veteran's Affairs for the ten (10) point preference
189
Microbiologist Resume Examples & Samples
- Experience with genome sequencing, sample preparation and analysis
- Experience with molecular diagnostic testing
- Experience working in clinical microbiology identifying human pathogens
- Experience dealing with customer service issues to resolution
- Experience in promoting a culturally competent and diverse work environment
190
Senior Microbiologist Resume Examples & Samples
- Schedule, coordinate and monitor a wide variety of microbiological, biological tests which are performed in accordance with approved protocol. Reviews results and final report or qualification
- Thorough knowledge in the concept of internal (BSC) and external regulatory requirements (QSR, ISO, EN) in the following subjects: microbial environmental monitoring, biocompatibility, contamination control, and quality assurance. Provide guidance to the Microbiology team on the application of the internal and external regulatory requirements
- Responsible for conducting internal audits on department test methods and activities to confirm compliance and to identify improvement opportunity
- Thorough knowledge of the Corporate Microbiology and Biocompatibility Policies and assisting site with compliance to the Corporate Microbiology and Biocompatibility policies
- Developing testing protocols for test method validations and writing up validation reports for tests
- Review equipment qualifications on major pieces of equipment, such as autoclaves, incubators, and refrigerators
- Troubleshooting existing test methods, improving test methods and adaptation of existing test methods to unique properties of devices. Troubleshoot excursions and guide
- Guide the manufacturing site in the analysis and interpretation of test results. Includes troubleshooting test excursions
- Support Regulatory submissions by conducting the final Microbiology review to ensure appropriate microbiology and biocompatibility information is present in the submission. Responsibility includes reviewing or writing the microbiology/biocompatibility summary and compilation of microbiology/biocompatibility reports
191
Microbiologist Resume Examples & Samples
- Independently performs moderate to highly complex level of clinical tests and accurately enters results
- Oversees preparation and testing of new reagents or controls and evaluates their usefulness
- Determines acceptability of specimens for testing according to established criteria
- Selects and evaluates control materials and data using established criteria; initiates corrective action
- Performs test calibrations and runs Quality Control material
- Evaluates the acceptability of routine analysis prior to releasing patient reports
- Accurately performs and records proficiency testing
- Initiates troubleshooting steps to evaluate testing failures. Notifies Supervisor
- Provide on-going technical guidance to Laboratory Assistants. Instructs new employees as to procedure
- Maintains professional growth through continuing education
- Responsible for performing preventative maintenance and/or calibration of laboratory equipment
- Demonstrates high level of integrity and honesty in maintaining HIPAA regulations
- Follow all laboratory policies and procedures including, but not limited to, general processes, safety and quality
- Trains staff in both routine and complex procedures
- Assists Supervisor in management of department. Takes on additional business related tasks as delegated by the Supervisor or Manager. This may include evaluation of new techniques and procedures in terms of personnel and space, method comparison, establishment of reference ranges, writing and revising technical procedures
192
Microbiologist Resume Examples & Samples
- BSc in Microbiology
- MSc
- 1-3 Years of relevant work experience
- Ensure to perform tests according to Gsk specification to meet the schedule
193
Supervisory Microbiologist Resume Examples & Samples
- Time in Grade (TIG) must be met by the closing date of the announcement
- Knowledge of budgetary formulation and travel procedures
- Knowledge of administrative operations of the organization
194
Microbiologist Resume Examples & Samples
- 5% International and 5% Domestic travel required
- One-year probationary period may be required
- Recruitment Incentive may be authorized: No
- To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login,
- To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf
- Fax your documents to 1-478-757-3144 . If you cannot complete the Application Package online, you may fax all of your materials. The complete application package must be submitted by 11:59 PM (EST) on Wednesday, April 26, 2017to receive consideration
- Veterans Preference Documentation, if applicable
- Proof of Education:Transcript(s)
- Schedule A Eligibility Letter if you are applying as a Schedule A candidate
195
Microbiologist Resume Examples & Samples
- 467567600
- Knowledge and application of laboratory procedures and techniques. Knowledge of different microbiologic methodologies, theories, and practices
- Focus on desired results and set and achieve challenging goals
- Assessment Questionnaire
- SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)
196
Microbiologist Resume Examples & Samples
- Be proficient in the use of numerous Laboratory instruments, software packages and microbiological techniques
- Be proficient in problem solving and may have expertise in troubleshooting equipment
- Experience in Environmental Monitoring and Microbial Limit Testing
- Be computer literate and competent in the use of Microsoft packages
197
Microbiologist Resume Examples & Samples
- 13+ years of applied medical device or pharmaceutical microbiological or biological testing, research and development, and/or sterility assurance experience
- Demonstrated expertise in a wide variety of microbiological concepts, practices, and procedures. Established as a Subject Matter Expert (SME) in Microbiology, Sterilization, Sterility Assurance, and Manufacturing Processes as they relate to the above areas
- Demonstrated expert knowledge of at least two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat, and possess a working familiarity with the others
- Demonstrated proficiency to maximize the biocompatibility of products using industry guidelines and advanced testing technologies
- Demonstrated ability to complete complex tasks using creativity, personal experience and good judgment. Ability to take an issue from concept to full completion of the task
- Demonstrated ability to decipher the meaning of, and where
198
Microbiologist Resume Examples & Samples
- 5+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience
- Must understand the fundamentals of two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat
- Demonstrated experience with biocompatibility tests, ability to interpret the associated industry guidelines
- Prefer demonstrated competency in advanced testing technologies
- Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures
- Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives
- Ability to effectively work cross-functionally with Product Development, Operations and Marketing
- Demonstrated ability to manage workload
- Demonstrated communication skills across different
- Organizational levels
- Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met
- Demonstrated ability to technically mentor associate engineers and scientists. Start Time: 8:00 AM
199
Microbiologist Lead of Mycobacteriology Laboratory Resume Examples & Samples
- A Bachelor's degree in Microbiology or a major in another laboratory science provided that at least 20 semester or 30 quarter credit hours in microbiology are included; AND three (3) or more years of experience in a microbiology laboratory
- Demonstrated experience in/with the following
- Responses to the Supplemental Questions
200
Microbiologist Resume Examples & Samples
- Prepare lab supplies
- USP & water testing; bulk pharmaceutical chemicals and drug product; culture maintenance; collecting samples; media preparation and qualification
- Data review and good documentation practices
- Environmental monitoring air and surface
- Bachelor's degree in Chemistry or related science from an accredited college or university
- Minimum of 1-3 years of related laboratory work experience in a pharmaceutical environment, or an equivalent combination of training and experience
201
Microbiologist Resume Examples & Samples
- Performs and becomes proficient in microbiological analysis for the detection of Pathogenic organisms and indicator organisms in food products and environmental samples. Primary focus is proficiency in Lab 2 with applicable tasks to include
- Ability to multi-task and work quickly while maintaining accuracy
- Must be able to see all colors of the visible spectrum
- Must be able to quickly adapt to implementing new methodology
202
Microbiologist Resume Examples & Samples
- Microbiological Science experience gained in the field of consumer / healthcare product development
- Ability to apply Microbiology principles and techniques to assigned product development projects. Good knowledge of Regulatory, GMP’s and ISO Quality management system standards
- Excellent oral & written communication and presentation skills, with ability to communicate confidently and build strong networks across the organization
- Demonstrated ability to take initiative, think and work independently
- A proven ability to apply effective influencing and negotiating skills
- Develops strong understanding of Microbiology procedures, international regulatory requirements and GSK quality systems
- Analyse Microbiological data, draw conclusions and provide expert summary for launch readiness as well as Regulatory submission
- Support new technology / product platforms by carrying out early stage DoE to identify strong antimicrobial systems. Generate scientific data to support Microbiology claims
- Expertly interpret the experimental data and generate scientific reports communicate with the internal project teams. Present microbiology data at internal and external meetings as required
- Independently lead microbiology support for projects by developing a strong partnership with project teams and implementing microbiology parameters for QbD
- Ensure all work is conducted in accordance with Good Laboratory practices and Health & Safety Practices
- Lead laboratory audits and investigations as necessary, including those related to OOS / OOT results
- Utilize the scientific network of Consumer Health R&D to leverage and build technical knowledge. Partner with external laboratory network to ensure confidence in the data generated
203
Microbiologist Resume Examples & Samples
- Bachelor’s degree, in Microbiology or Biology preferred
- 0-3 years of relevant GMP/GLP laboratory experience in regulated industry preferred
- Capable of both written and verbal effective communications skills including presentations
- Knowledge of MS Office Suite
204
Microbiologist Resume Examples & Samples
- Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release
- Support development and implement plant-wide Microbiological Control Program
- Support, maintain and utilize SPC system to drive continuous improvement, identify trends and draw conclusions
- Assist with product, equipment, and C&S validations
- Maintain lab equipment and calibrations
- Complete Failure Investigations and properly document Out of Specification results
- Support implementation and role out of Global Quality Standards
- Provide product release notification to Colgate distribution system and SAP transactions
- Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions
- Approve raw materials shipments and ensure Raw Material Purchasing Specification is met on the CofA’s
- The position does require flexibility, shift work (sick, vacation coverage, etc) so as to best meet the facility’s needs and support projects
- Bachelors of Science in Microbiology or related field
- Working Knowledge and practical Experience with good laboratory practices (GLP’s) - General Microbiological laboratory practices
- Instrumentation (such as Celsis, autoclaves, gram staining, water purification system, etc)
- Ability to conduct a failure investigation of any nonconforming products
- Must understand basic lab safety and chemical waste disposal processes
- Practical Knowledge of laboratory working environment is required through job experience or college classwork
- One year of practical microbiology laboratory experience
- Results Orientation - Displays a high energy level, and puts top priority in getting results
- Ability to Make decisions and communicate effectively while under pressure
- Team Building/Relationship Building - Develops relationships with people throughout the facility
- Communication - Speaks and writes effectively, and keeps people up to date with information. Maintains lab notebooks and testing documentation
- Innovation - Generates innovative ideas and solutions to problems and stimulates others to continuous improvement
- Excellent interpersonal, communication skills and ability to work in a team environment
- Strong multitasking skills in a fast paced, changing environment
205
Principal Microbiologist Resume Examples & Samples
- Provide microbiological and sterilization expertise to quality, manufacturing, technical services, engineering and R&D throughout all phases of project including routine manufacturing, innovation, development and technology transfer
- Author and review assessments, procedures, technical reports and other sources of information to ensure that microbiology sampling and testing methods are consistent with current industry practices and regulatory requirements
- Coordinate method development, validation and testing with internal and external microbiology laboratories for a wide variety of testing pertaining to R&D projects
- Author and review test protocols/data/reports for validating new products /processes to ensure conformance with established specifications and related standard operating procedures
- Anticipate /evaluate technical problems and provide recommendations for corrective actions
- Write, collect, organize and compile data and reports for use by upper management and to comply with regulatory requirements
- Interface with pertinent disciplines to evaluate applicability of existing methods
- Review and/or develop specifications for raw materials, components and finished products
- Evaluate, specify and justify Microbiology and Sterilization requirements for major capital projects
- Represent company on microbiology and sterilization topics during interactions with regulatory agencies, including interface with FDA inspectors
- Participate on cross-functional teams to resolve issues
- Manage microbiology and sterilization validation programs for new products (including changes to containers, closures or solutions)
- A strong scientific knowledge in areas pertaining sterilization approaches and processes (moist heat, VHP, radiation, aseptic fill, isolators, RABS)
- Knowledge of environmental, utility and facility monitoring programs, including area classifications. Familiarity with equipment installation and qualification and electronic data systems. Awareness of general cost structure pertinent to microbiological testing and validation
- Strong problem solving and troubleshooting capabilities. Good written and verbal business communication skills. Must be able to work productively in a cross-disciplinary environment
- Degree in Microbiology, Molecular Biology, Biochemistry, or a related science with significant microbiology coursework
- Pharmaceutical industry experience at least 8-12 years in a cGMP environment
- Strong technical expertise in areas related to: sterility testing, bioburden, endotoxin levels, particulate matter limits, and biological indicators (manufacturing, testing & use)
- Demonstrated industry experience in several of the following areas: microbiological method development and validation, D&z value determination, cycle time reduction (CTR) studies, container-closure integrity testing (CCI), microbial ingress and dye penetration studies
- Experience in qualification of raw materials and components used in GMP manufacturing. Generation of microbiological specifications in alignment with Compendial requirements (for US, and preferably also for EU)
- Hands-on experience in addressing microbiology and sterilization related topics in regulatory submissions. Experience interacting with regulatory agencies
- Limited domestic and/or international travel may be required
- A Ph.D. or Masters degree is highly preferred
- Experience with manufacturing of large volume parenterals is preferred
206
Junior Project Microbiologist Resume Examples & Samples
- Creation of Technical Reviews, specifications and other mandatory documents regarding sterilization and biological evaluation for regulatory submissions
- Coordination, review and approval of product sterilization validations (e.g. dose audit)
- Internal technical document creation and approval
- Resource for sterilization and cleaning issues for new product development
- Biocompatibility assessment and organization of respective testing
- Endotoxin assessment, organization and trending
- Reusable device cleaning and sterilization review and validation
- Review and preparation of procedures and documents to keep pace with AAMI/ISO standard development
- Support the (senior) project microbiologists for special projects
- Bachelor’s degree in relevant scientific disciplines, such as microbiology, cell biology and molecular biology
- Experience in leading projects
- Ability to solve a variety of complex sterilization, microbiological and contamination control issues
- Good knowledge of industry standards (AAMI, ISO, ASTM etc). and regulations regarding medical devices
- Good understanding of the principles and requirements of current Good Manufacturing Practice (cGMP)
- Strong problem solving skills and ability to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner
- Fluency in German and English, also written, in scientific language
207
Microbiologist Resume Examples & Samples
- Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
- Perform environmental monitoring of the clean rooms (under ISO and EU specifications)
- Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results
- Perform microbial characterization (gram stain, catalase, oxidase, and couagulase tests)
- Maintain historical files on organisms found in classified areas; microbial identification and trending
- Perform line clear and line start verifications
- Inspection of media fills
- Perform other microbiological assays
- 0-2 year’s lab experience with degree or equivalent education and lab experience
- Intermediate/advanced ability in Word, Excel, Outlook
- Advanced knowledge of scientific principles and concepts
- Strong mathematical and reasoning ability
- Ability to work independently as well as in a team environment
- Effectively communicate, verbally and in writing, and interpret and follow instructions
- Ability to work under pressure to meet deadlines
- Attention to detail, organization, and thorough documentation
208
Microbiologist Description Resume Examples & Samples
- 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. OR equivalent doctoral degree in microbiology, or specific area of study such as bacteriology, virology, mycology, algology, protozoology, parasitology, immunology, serology, microbial genetics, or soil microbiology; or specific applied fields of microbiology such as clinical and public health microbiology, food technology, production processes, industrial fermentation, pollution, etc. Graduate study in related fields such as experimental pathology, infectious diseases, epidemiology, biochemistry, animal or plant physiology, genetics, plant pathology, and insect disease control, may also be pertinent, provided it has direct application to microbiological work. OR a combination of experience as describe in "A" above and graduate education as described in "B" above. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify
- Knowledge of principles and techniques related to the analysis, presentation, and exchange of data
- Gain the trust of others by taking responsibility for own actions and telling the truth
- Knowledge and application of laboratory procedures and techniques
- Knowledge of different microbiologic methodologies, theories, and practices
- Deliver clear, effective communication and take responsibility for understanding others
- Apply scientific principles; techniques to develop/enrich knowledge of a topic & advance science
- Commit to satisfying internal and external customers
209
Microbiologist Sampling Specialist Resume Examples & Samples
- Tracks lab supplies and expiration dates; orders, receives, holds, and releases inventory
- Interacts with vendors to resolve issues, set custom orders and track shipment status
- Places outgoing sample and equipment shipment requests
- Tracks and completes monthly preventive and calibration work orders
- Performs sampling of Raw Materials (i.e., packet info, STM, C of checks, incoming inspection and release labeling)
- Issues, tracks, creates, reconciles and files Logbooks and controlled data sheets
- Appropriately manages biohazardous waste
- Performs growth promotion testing (i.e., qualification of lab media fluids and reagents)
- Oversees monitoring of thermal units, including record keeping and documentation of exceptions
- Writes and revises SOPs and training materials
- Samples air, water, and surfaces in controlled and restricted production areas, including special production operations
- Tests environmental samples, evaluates results, and enters results into electronic data system
- Tests samples for general assays as needed, with evaluation and recording of corresponding data
- Assists supervisors, managers and laboratory scientists with projects, as required
- Double gowning for manufacturing environment required
- Bachelor's degree in biology, chemistry, biochemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
210
Microbiologist Resume Examples & Samples
- 2 Samples and tests utilities as per system SOPs and test program, when required
- 3 Performs environmental monitoring in all areas (Non-sterile production areas and support areas) as per SOP and test program
- 7 Examines samples critically
- 8 Records results as per GLP requirements
- 9 Reviews results for accuracy and reports any anomalies or non-conformances to Manager
- 10 Implements OOS procedure where necessary
- 11 Performs `peer review’ of microbiological test results
- Compliance GLP & QMS
- 7 Verifies the calibration status of equipment as required by the Manager
- 8 Performs maintenance of equipment as required by the Manager
- 9 Completes appropriate equipment logs after usage, verification and maintenance contemporaneously
- 10 Assists with the validation of equipment and systems as required by the Manager
- 11 Performs system monitoring (eg. Room pressures) and completion of appropriate logs as required by the Manager
- 14 Interacts with value stream management on matters related to operational and product microbiological quality. Attends monthly Valuestream Quality Councils as required
- 15 Provides advice, guidance and training as required by Manager
- 16 Carries out microbiological tests for cleaning validation and process validation purposes
- 17 Participates in the Zero Defect Promotion (B2B) to promote a good quality culture
- EHS
- 1 Complies with EHS standards and guidelines and Site EHS SOPs
- 2 Complies with SOPs wrt safe use of chemicals/reagents, glassware, analytical procedures and the use of PPE
- 3 Participates in the Zero Accident Promotion (B2B) to help promote safer working conditions
- GSK Production System
- 3 Assists with the delivery and achieving the GMS goal of Zero Accidents, Zero Defect and Zero Waste goal on site
- 4 Participates in “visual factory”, incorporating 5S
211
Microbiologist Resume Examples & Samples
- Degree in Science with a speciality in Microbiology
- Post qualification experience of at least 5 years
- Experience of the following would be beneficial, but is not essential
212
Lead Microbiologist Resume Examples & Samples
- 1) Serves as a Microbiologist I, testing customer samples which include
- Sample dilution, plating, running rapid test kits and media QC set-up
- Reading and interpreting results
- Peer review of test results and sample approval into the LIMS system as requested
- Aid in the investigation and disposition of out-of-specification test results
- Ensure that all tests are set up using the appropriate methods and techniques
- Review the batch components each day for accuracy and completeness
- Manages next batch action report to ensure timely testing and reading of samples
- Monitors Checkpoint system
- Manages overdue report (daily)
- As new methodologies or equipment are implemented, serve as the lead for troubleshooting any questions/issues
- Serves as a liaison between Sample Prep. and the micro. lab to ensure that sample flows is efficient and communicates any needed tests
- 2) Ensure the department is compliant with the Quality System
- Evaluates the current policy to suggest changes regarding Standard Operating Procedures, forms, tests and training
- Conducts work in a manner that is compliant with the Quality System and all ISO 17025 requirements
- Works with Training and QS Coordinator to ensure proficiency testing is complete and submitted on time
- Enforces the Chemical Hygiene Plan and safety programs
- Accurately performs and documents equipment calibrations and preventative maintenance
- Ensures all samples are set up, reviews batch reports and signs off that testing was completed
- Monitors the LCS (laboratory control sample) records to ensure all tests are complete
- Manages next batch action reports and ensures samples are read on time
- Manages the overdue testing report; runs each day and turns in a copy to Client Services Representative
- Operate, troubleshoot, clean, calibrate/qualify and maintain microbiology instruments
- Assist QSA to implement necessary corrective actions regarding PAR/CAR's and offer suggestions for improvement to processes/programs
- Monitors the checkpoint system for compliance
- Assist in monitoring KPI's for the department
- 3) Coordinates any "project" work
- 4) Communicates daily media needs to the media department
- 5) Monitors all PCR/ELISA/ELFA testing results and plate runs to look for compliance
- 6) Serves as the liaison between sample prep. and microbiology to ensure batches are created in the proper order and samples are available for testing
- 7) Assists with training efforts for new employees
- 8) Participates in the internal audits as requested
- 9) Works with the QSA and Purchasing Coordinator to ensure the proper approved supplies are kept in stock. Assist with performing physical inventory at month end for department
- 10) Ensures laboratory cleanliness (counters, fixtures, equipment, shelving, floors, etc. and reports concerns to the QSA or Director
- Minimum of a Bachelor's degree (BA or BS) in Microbiology, Biology, Cell Biology or Equivalent; 5+ years of prior food laboratory experience preferred. Master's preferred
- Must have achieved Micro I status for 3 years - internal candidates
- Prior use of ELISA and PCR detection techniques
- Knowledge of USDA, FDA, AOAC, ISO and IDF methodologies
- Experience testing multiple food matrices (dairy products, raw and ready to eat meat products, produce, etc.)
- Prefer prior successful experience managing processes/projects
- Good verbal and written business communication skills
- Ability to multi-task and work quickly while maintaining quality and accuracy
- Understand sample and reagent preparation processes and calculations including dilutions and percent solutions
- Ability to follow analysis protocols and approved standard methods, understand the effects of protocol deviations on analytical results, and monitor the results for validity
- Ability to assess multiple microbiological protocols and determine the appropriate method of analysis to obtain accurate and valid results
- Ability to follow quality control and quality assurance protocols to ensure the validity of test results and safety of the work environment
- Ability to collect data, interpret findings, draw valid conclusions, and identify discrepancies and/or invalid results
- Ability to apply advanced mathematical concepts such as exponents, logarithms, and advanced Algebraic equations. Ability to determine percent error, variance, standard deviation, correlation and regression, and dilution calculations. Ability to interpret complex chemistry equations and manipulate equations in troubleshooting situations; understand basic statistics such as mean, z-scores, t-tests, acceptance criteria etc
- Ability to define and resolve problems through critical evaluation of issues
213
Senior Microbiologist Resume Examples & Samples
- Responsibility for the implementation and maintenance of the microbiological programme including environmental monitoring programmes, (air, surface and particulate) and purified water process monitoring
- Responsible for the validation of contract sterilisation for both Gamma Irradiation and EO sterilization as per ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11135-1
- Responsible for the maintenance of the quarterly Dose Audit programme for all sterilization families
- Responsibility for implementing regulatory requirements in accordance with ISO13485, FDA QSR 21CFR Part 820
- Involvement in Cleanroom validations, Water system validations and Cleaning validations
- Preparation, execution and analysis of related Quality documentation
- Support the internal audit program
- Involvement and general support to the Quality group including execution of assigned projects
- Third level Qualification in Microbiology with at least 5 years’ experience in a similar role (relevant experience in same with equivalent third level Science Qualification will be considered)
- A strong knowledge of water systems, Cleanrooms, biocompatibility and sterilisation is desirable
- Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP
- Knowledge of medical device quality standards/practices or similar regulated industry such as ISO10993, EN550, EN ISO 11135-1 and 11737-1
- Knowledge of regulatory requirements
- Good knowledge of CAPA, NCR and deviation process
214
Senior Microbiologist Group Leader Resume Examples & Samples
- Manage microbiology lab and staff for routine microbiology testing of tobacco related products
- Perform routine and non-routine microbiological analyses and related procedures, record and document data according to regulatory requirements
- Operate and maintain laboratory equipment, perform equipment troubleshooting and maintenance, recognize errors, identify root causes, apply process improvement; maintain excellent working knowledge of laboratory equipment
- Lead and foster motivation in team, schedule and train employees in client environment, provide performance evaluations
- Ensure adherence to ISO 17025 Quality System, efficiency standards and any regulatory requirements in laboratory operations
- Coordinate workflow, ensure sufficient coverage and performance to meet turnaround times
- Prepare written documents (including but not limited to work instructions, standard operating procedures, protocols, reports, and investigations)
- Review data in laboratory LIMS (Laboratory Information Management System), data notebooks/data packets and reports
- Ensure excellent understanding and user ability of laboratory LIMS system
- Ensure safe work practices are followed in the microbiology lab
- Maintain knowledge of current and improved technologies available for microbiology
- Communicate effectively with client staff members
- Lead team, schedule, and train employees in client environment
- Ensure adherence to highest quality and efficiency standards in laboratory operations
- Ensure coverage and performance
- Foster morale and teamwork
- Experience in GMP/GLP and/ or ISO compliance laboratory environment
- Strong leadership, initiative, and teambuilding skills
- Bachelor’s degree in microbiology, biology or other related degree concentration, or equivalent years of experience where 2 years of experience equals 1 year of education
- 5 years microbiology laboratory or related experience
215
Microbiologist Resume Examples & Samples
- Four year degree in microbiology or related science, or a four year degree and work in the field of microbiology
- Two to three years in a medical device, medical, pharmaceutical, food industry, or related industry (FDA controlled)
- Two to three years in microbiology and/or sterilization
- Person in this position demonstrates professional skills with excellent written communication
- Able to work with minimal supervision and ability to maintain regular and predictable attendance
- Ability to travel approximately 5-10%, including internationally
216
Microbiologist Resume Examples & Samples
- Isolation of DNA from tissue and body fluids/samples
- Use of PCR in identification of microbial agents
- DNA sequencing and sequence analysis
217
Microbiologist Resume Examples & Samples
- The fundamentals of bacteriology, parasitology, serology, mycology, virology, and other microbiological principles
- Chemical principles of the examination of body fluid, food, and water
- Public health laboratory procedures and techniques,
- Common causes of disease and the methods of transmission and control of communicable diseases
- Laboratory equipment and its care
- Perform public health laboratory tests
- Follow oral and written instructions
- Work cooperatively and effectively with others
- Observe safety precautions and procedures
- Keep records and make reports
- 2) Those candidates who possess the minimum qualifications for the class will be placed on the eligible list based on an evaluation of education, training, and experience. Candidates must attain a qualifying rating on each portion of this examination
218
Microbiologist Resume Examples & Samples
- Associate degree in biology, microbiology, chemistry or other related field required
- Previous experience with ISO and GMP
- Previous laboratory techniques such as pipetting, aseptic techniques
- Good documentation practices
- Good organization skills and ability to multitask are desired
- Strong verbal and written communication skills and ability to work effectively on teams is a must
219
Microbiologist Resume Examples & Samples
- Ensure plant compliance with all Hygiene, HACCP, Sanitation and GMP requirements
- Microbiology- understanding the program and being responsible for all micro activities to sustain the program (sampling, plating, reading, Lab ICP)
- Troubleshooting microbiological issues resulting from results of processes and CIP activities
- Supporting and troubleshooting QA issues on the production line
- Sensory – setting up finished product and odor panels in accordance with sensory program
- Performing calibrations on measuring and monitoring equipment; ozone sensors, pH meters, conductivity meters, TDS and turbidity meters
- Monitoring the quality of the product on the 1st shift, by line releases, duplicate checks and incidence reports
- Water treatment testing on incoming water from city and springs, including reverse osmosis system operations
- Customer Complaint testing and troubleshooting
- Testing and verifying equipment used for water treatment on city lines and process lines
- Monitor and advise when CIP activities and external cleaning is needed
- Degree in Microbiology, Chemistry, Biology or related science or demonstrated equivalent experience in microbiology lab preferred
- Flexibility for Weekend Work when Needed for Reading Plates and Quality Support for Saturday or Sunday Production
- Physical Capability of lifting more than 50 lbs
- 1-3 years experience in microbiology plating methods highly preferred
- Knowledge of RO, CIP, and Cleaning Systems
220
QC Microbiologist Resume Examples & Samples
- Perform microbiological testing (endotoxin, bioburden) for water
- Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests)
- Prepare and send out samples for microbiological identification
221
Microbiologist Resume Examples & Samples
- Sampling, qualitative and quantitative microbiological examinations including, but not limited to testing EB, AMC, Staph, B. cereus, yeast, mold, pH and other related analysis using both direct streak and pour plate for incoming materials, finished product and investigations
- Sampling and testing as applicable utilities systems including pH, sensory and microbiological analysis
- Prepares, reviews, and reports results of microbiological analyses; maintain and document records in accordance with established procedures
- Maintenance of the environmental monitoring program including sampling, testing, data entry and reporting results
- Ensure maintenance and calibration program for analytical instrumentation and equipment within the laboratory
- Maintenance of MCS control organisms
- Cleans-up and general maintenance of laboratory and work area
- 1-2 years’ experience in a microbiology laboratory or setting is preferred
- Effective communicator with training, facilitation, and supervisory skills
- Must be capable of working with minimal direct supervision and have strong prioritization, interpersonal, and self-initiative skills
- Computer skills to include proficiency with the Microsoft Word and Excel required. Access, SAP and Statistical software experience is preferred
- Expertise in microbiological analysis
222
Microbiologist Technician Resume Examples & Samples
- Prepare samples for analysis in a timely and efficient manner
- Monitor and dispose of outdated samples, maintaining order in sample storage
- Prepare media and reagents
- Perform test methods as documented
- Clean glassware as specified in the test method
- Maintain good housekeeping at all times to ensure a clean and safe work environment, comply with all rules and responsibilities as outlined under the corporate Health and Safety Policy
- Request supplies and consumables in advance of requirement by recording needed items in order book
- General duties as directed by the team leader or lab manager
223
Microbiologist Resume Examples & Samples
- Perform microbiological testing of raw materials, water, work-in-process, and finished product for product approval and release
- Support, maintain and utilize KPIs system to drive continuous improvement, identify trends and draw conclusions
- Assist with product, equipment, and Cleaning & Sanitizing validations
- Responsible for the maintenance of the Laboratory Quality Control Systems
- Knowledgeable of cGMP’s and understand the OTC drug or pharmaceutical industry expectations
- Provide Microbiology and Cleaning & Sanitization related Training to plant employees
- Trouble shoot laboratory issues and provide resolutions from audits
- Purchase laboratory supplies
- B.S. in Microbiology or related Science
- Experience with basic lab equipment such as pH, balances, viscometers, etc. and microbiology methods
- Experience with general documentation practices and cGMP compliance with notebooks, data entry forms with specific attention to details
- Experience with common microbiology lab instrumentation (i.e. autoclaves, air amplers, light microscope, biohazard cabinets, and water purification system.)
- Familiar with quality systems such as failure investigations, Corrective and Preventive Actions, calibration, change control, etc
- Good computer skills (i.e. MS Word, MS Excel, e-mail)
- Must understand basic lab safety, bio-hazard and chemical waste disposal practices
- Ability & Flexibility to work a rotational schedule to support a 24/7 plant facility operation
- Team Building/Relationship Building - Develops relationships with people throughout the facility and demonstrate team work
224
Microbiologist Resume Examples & Samples
- Lead assigned Projects
- Diploma /Bachelor of Science (Microbiology /Chemistry) or related field or equivalent
- Fresh Degree /Diploma with Min 3 years or
- Degree with Min 3 years /Diploma with Min 6 years
- Some relevant working Experience
- Technical knowledge on lab equipments/ system/ software/ validations
225
Microbiologist, GS Resume Examples & Samples
- Annual Leave for non-federal service authorized: May Be Authorized
- Time in grade (TIG) must be met within 30 days of the closing date of the announcement
- Ability to gain the trust of others by taking responsibility for own actions and telling the truth
- Knowledge of principles and techniques related to the analysis, presentation and exchange of data
- Ability to commit to satisfying internal and external customers
226
Microbiologist Description Resume Examples & Samples
- Travel, transportation, and moving expenses will be paid: No
- Bargaining Unit Position: No
- Drug Screening Required: No
- Recruitment Incentive authorized: No
- Research position:No
- Supervisory position: No
- Promotion potential: No
- Time in grade (TIG) must be met within 30 days of the closing date of the announcement
- Current or Former Political Appointees: Agencies must seek prior approval from the Office of Personnel Management (OPM) before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5, United States Code. If you are currently, or have been within the last 5 years, a political Schedule A, Schedule C, or Non-career SES employee in the executive branch, you MUST disclose that to the Human Resources Office. Failure to disclose this information could result in disciplinary action including removal from Federal Service. Current or Former Political Appointees: Submit SF-50
- OR-
- Knowledge of different microbiologic methodologies, theories, and practice
227
Microbiologist Description Resume Examples & Samples
- One-year probationary period may be required
- Recruitment Incentive may be authorized: No
- Annual Leave for non-federal service authorized: No
- Research position: No
228
Microbiologist Description Resume Examples & Samples
- Establish and maintain relationships for the purpose of achieving business goals
- Build professional skills and competencies and improve work processes
- Make decisions in a timely manner
- Recognize each person's differences and utilize those to increase organizational effectiveness
- Knowledge of management & administrative techniques designed to ensure effective lab operations
- Working with team members and colleagues to achieve a common goal
- Accurately assess problems and effectively and efficiently arrive at effective solutions
- Focus on desired results and set and achieve challenging goals
- Provide training, consultation, or other guidance to others
- The ability to prepare, present, teach, and publish reports and manuscripts of laboratory research
229
Microbiologist Resume Examples & Samples
- University graduate in Microbiology
- 2-3 year experience in Food manufacturing company is preferred
- Influence with integrity
- Enable results through others
- Energize & engage the team
- Coach & develop the team
- Courage
230
Senior Microbiologist Resume Examples & Samples
- Conducts analysis of liquid and air samples
- Conducts USP sterility testing, USP particulate testing, bacterial endotoxin testing and pre-sterile bioburden testing of pharmaceutical solutions
- Development and validation of microbiological test methods
- Documentation and reporting of microbiological tests
- Environmental monitoring of plant controlled areas
- Performs bacterial endotoxin testing of raw materials and solutions
- Performs tests to assure compliance with company specifications, GMP and ISO requirements
- Prepares cultures and biological indicator solutions used for plant validation and product development studies
- Supports the sterility assurance and environmental monitoring programs for Corporate and other Haemonetics facilities
- Technical administration and operation of the microbiology laboratory including safety and training
231
Microbiologist Resume Examples & Samples
- AA Degree with 6 year’s experience, BS Degree with 4 year’s experience or MS Degree with 2 year’s experience in an OTC Manufacturing laboratory
- Minimum of 5 year's hands-on experience supporting cGMP manufacturing environment
- Minimum of 5 year's hands-on experience in a leadership role in a laboratory environment
232
Microbiologist Resume Examples & Samples
- Perform tissue culture and molecular biology laboratory experimental duties including solution and media preparation, plant tissue culture, molecular cloning and other lab procedures following predefined protocols
- Independently design and perform molecular biology and plant transformation experiments
- Ability to perform basic calculations
- Basic molecular biology experience working with PCR, DNA extraction, aseptic techniques etc
- Experience with media and solution preparation
- Science based Bachelor's degree (microbiology, molecular biology, biology, chemistry) or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- More than 5 years of plant, microbiology or biology experience
233
Microbiologist Per-diem Resume Examples & Samples
- Releases error free computerized laboratory reports for review
- Prints and distributes appropriate reports for pharmacy and infection control
- Operates the laboratory computer system with expertise in the microbiology module
- Solves minor software and hardware problems with computer support personnel
- A baccalaureate degree in clinical laboratory or related sciences, with one-year hospital clinical training in an approved program
- Must have working knowledge of all areas in microbiology, parasitology and immunology. Review journals and attends meetings and seminars to keep informed of new developments and technology
- Must be able to work with extreme care and accuracy at all times, even under pressure
- Must be able to demonstrate a high degree of professionalism and practice good public relations at all times
- Excellent computer skills, strong written and verbal communication skills required
- Ability to perform complex tasks, prioritize multiple projects, and work under pressue to meet deadlines in a fast-paced environment
- Technical and analytical skills for analysis and interpretation of test procedures and/or results in order to determine appropriate correction actions
- Proficiency with working with spreadsheets and/or reports and able to run specialized reports when needed
234
Microbiologist Description Resume Examples & Samples
- Travel, transportation, and moving expenses will be paid: Maybe Authorized
- Research position: Yes, Since this is a research position, an evaluation of the scientific contributions, recognition and professional standing of the researcher as they relate to the position being filled will be made to determine qualifications. Candidates should include all pertinent information regarding their research accomplishments, e.g.list of publications and presentations
- Cost of Living Allowance (COLA): Yes, 4.22%
235
QC Senior Microbiologist Resume Examples & Samples
- Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability)
- Establish user requirements for purchase, qualification of Kite’s QC equipment and work with internal and external resources to maintain equipment in an optimal state
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of areas of responsibility
236
Microbiologist Resume Examples & Samples
- Microbiologist
- MS or higher (Microbiology, Food Microbiology or related Major) preferred. Bachelors is required
- 1 to 5 years of R&D (technical, product application development) experience in meat/food science. A track record of successful meat/food science related research and publications are strongly preferred
- Experience of managing BSL- 2 microbiologist lab is preferred
- 2-3 years of relevant lab experience
- 1-5 years of research and development experience in meat and/or food processing
- Excellent interpersonal, communication and organizational skills
- Self-starter, proactive and able to manage your own time effectively
237
Lead Microbiologist Description Resume Examples & Samples
- All qualification requirements must be met by the closing date of the announcement
- Travel, transportation, and moving expenses will be paid: No
- Bargaining Unit Position: No
- Drug Screening Required: No
- Recruitment Incentive may be authorized: No
- Research position:No
- Supervisory position: No
- Promotion potential: No
- Time in grade (TIG) must be met within 30 days of the closing date of the announcement
- Establish and maintain relationships for the purpose of achieving business goals
- Build professional skills and competencies and improve work processes
- Commit to satisfying internal and external customers
- Make decisions in a timely manner
- Recognize each person's differences and utilize those to increase organizational effectiveness
- Gain the trust of others by taking responsibility for own actions and telling the truth
- Knowledge of management & administrative techniques designed to ensure effective lab operations
- Knowledge and application of laboratory procedures and techniques
- Knowledge of different microbiologic methodologies, theories, and practices
- Deliver clear, effective communication and take responsibility for understanding others
- Accurately assess problems and effectively and efficiently arrive at effective solutions
- Apply scientific principles & techniques to develop/enrich knowledge of a topic & advance science
- Focus on desired results and set and achieve challenging goals
- Provide training, consultation, or other guidance to others
- The ability to prepare, present, teach, and publish reports and manuscripts of laboratory research
- Express oneself clearly in business writing
238
Microbiologist Resume Examples & Samples
- Perform routine and non-routine microbiological testing according to established procedures or approved protocols
- Perform raw material, intermediate, final product testing; and routine and non-routine microbiological testing. -Document results clearly and accurately
- Interpret results by comparing against appropriate specifications or requirements
- Perform Data reviews and release inspection lots in the material management system
- Calibrate and maintain laboratory equipment and maintain supplies inventory levels
- Participate in laboratory investigations, technology transfer, validations and R&D projects
239
Assoc Microbiologist Resume Examples & Samples
- Performs assigned Standard Operating Procedures on product/material samples under development
- Evaluate new technologies, products and materials as assigned
- Follow all procedures related to data documentation, laboratory safety, and good laboratory practices
- Recognizes malfunctions in laboratory equipment and advises supervision or performs simple repairs
- Writes, reviews and/or updates Standard Operating Procedures as assigned
240
Microbiologist Resume Examples & Samples
- B.S degree in Microbiology or related field preferred
- Understanding the microbiological testing analysis
- Auditing skills
- Microweb Database
- Basic Ion Chromatography Knowledge
- Candidate must also be able to perform several tasks simultaneously
- Commitment to NWNA Aspirations and Beliefs
241
Senior Microbiologist Resume Examples & Samples
- Supervise the microbiology team, manage its tasks, professional direction
- Continuous development of the laboratory according to the GMP
- Introduction of new microbiological procedures if applicable
- Monitoring of the laboratory cost, suggestion for cost savings
- Orders media, material and equipment necessary for microbiological analysis
- Microbiological monitoring of the site environment
- Make efficient use of outside (contract testing facilities, consultants etc.) resources to support laboratory activities
- Takes part in preparation, control and implementation of SOPs related to the function
- Planning and review of testing methods according to GMP and internal regulations
- Revision of test specifications and checking compliance of test specifications with protocols
- Conduct investigations, recommendation for corrective and preventive actions
- Reading and registering the microbiological test results
- Execute microbiological analysis according to the relevant SOPs, procedures and national standards. Microbiological testing of potable/tap water, purified water, compressed air and solid and liquid drugs
- Perform suitability of the test method for drug testing
- MSc graduate of microbiology or biology
- 5+ years of pharmaceutical work experience
- Knowledge of microbiological quality assurance tools and measuring equipment (autoclave, microscopes, laminar boxes etc.) and experience in their calibration
- Knowledge of measurement technology, statistics and GMP
- Computer knowledge on user level (MS Office)
- Quality Assurance and Documentation Handling knowledge
- Problem-solving ability
- Good organizational, communication skills
- Strong English
242
Microbiologist Resume Examples & Samples
- Perform serial dilutions, routine and non-routine microbiological plating and enumeration of samples, water activity, and moisture analysis following prescribed methods
- Perform validation of methods, and media
- Perform data entry and review of data
- Operate, maintain, and troubleshoot laboratory equipment
- Perform instrument calibration, daily equipment checks
- Participate in laboratory investigation, exception, and CAPA process
- Accurately documents results in notebooks and laboratory LIMS, in compliance with good documentation practices
- Adheres to highest quality standards; ensures compliance with quality system requirements
- Communicates effectively with client staff members and co-workers
- GMP/GLP/ISO17025 experience
- Familiarity with laboratory asceptic technique
243
Microbiologist Resume Examples & Samples
- Provide essential microbiological analytical laboratory services for food and beverage manufacturers, private sectors, commodity exporters companies and food industry in line with the Company standards
- Maintain accurate records of all performed procedures in assisting in implementation of ISO/IEC 17025:2005 in the laboratory
- Maintain the good laboratory housekeeping and ensure Health, Safety and Environment (HSE) standard are adhered
- Perform all analytical testing for the samples, recording and updating of results in LIMS
244
Microbiologist Resume Examples & Samples
- Data analysis and reporting - Using agreed formats, record experimental data and prepare reports on work undertaken. This includes presenting initial analysis, conclusions and recommendations as a basis for further discussion and research
- Problem Resolution - Work to resolve technical/scientific problems in a timely manner by collaborating with other wound biology functional experts. Participate in related discussions that identify relevant theory and practical interventions
- Functional/Technical Expertise - Develop and maintain understanding of the latest microbiology theories and research initiatives and make recommendations internally about any related changes to current methods and working practices. Develop and share expert functional knowledge, educating individuals across both NPD and the wider AWC team. Maintain a network of internal contacts who can defer to for advice when appropriate
245
Microbiologist Resume Examples & Samples
- Ability to analyze techniques, trouble-shoot and maintain a variety of equipment, keep records, and provide quality control assurances is essential
- Ability to keep current and accurate records and enter data into database systems. Basic computer skills are necessary
- Ability to communicate clearly, interact effectively, and work well within a team-oriented operation
- Effective written and verbal communication skills, including teamwork and customer service skills
- Must be highly motivated, careful and willing to adapt to new procedures
- Ability to operate or learn to operate the alkaline hydrolysis tissue digester and overhead hoist system is
- Knowledge of biological safety handling procedures and appropriate disposal of biological hazards
- Knowledge of Quality Assurance and Standard Operating Procedures
- Knowledge of laboratory procedures, lab equipment operations and equipment maintenance techniques
- Ability to maintain confidentiality of test results
246
Entry Level EM Microbiologist Resume Examples & Samples
- Passive/Active Air Sampling (ability to routinely lift 20-30 pound air sampler)
- Surface sampling
- Perform utility sampling – steam, gas, water – and deliver to lab for analysis
- Ensure all work is performed/documented in a GMP compliant manner and per applicable regulatory and client requirements
- Participate in lean lab operation, 6S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs
- Conduct and document investigations as needed
- Perform other housekeeping tasks as needed to maintain area (glassware washing, inventory/restocking of supplies, etc)
- Participate in cross-training functions as needed to support QC area
- Prior experience in a Quality Control environment
- Knowledge of GMPs, safety regulations, and data integrity
- Understanding and application of cGMPs in a production environment
- Familiarity with USP1116, ISO14464, and Annex 1
- Bachelor's degree in scientific discipline
- Perform weekend-work on rotational basis to support manufacturing operations
247
Microbiologist Resume Examples & Samples
- Perform weekly, monthly and quarterly environmental monitoring tests
- Trend data for environmental monitoring
- Perform Bacterial Endotoxin Test
- Perform Product Bioburden Tests
- Test of sterility of BIs
- Media Growth Promotion
- Assist in nonconformance investigation
- Track, perform and report FMA test requirements
- Track and acquire product bioburden samples for quarterly tests
- Write Quarterly Environmental Reports
- Prepare samples and test request forms for external contract tests
- Coordinate and execute CEA recertification efforts
- Perform product radiation dose audits
- Train other Microbiologists
- Perform and write reports for quarterly dose audits radiation product families
- Perform annual EO sterilization cycle revalidations
- Lead Investigations for NCE, RCI, CAPA
- Serve as microbiology and sterilization member on product development teams
- Evaluate data to support sterilization validation runs
- Understands EO residual and tolerable contact limit applications
- Working understanding of D-Value and SAL
- Develop and implement test methods to support environmental or product testing
- Completes annual continues improvement project
- Determine impact of Gap analysis of standards
- Serve as a SME in at least one departmental area
- Two years of relevant experience required
- Excellent organizational skills (schedules, prioritization, traceability) required. Must be computer literate and have a thorough understanding of basic laboratory and aseptic techniques
- Understanding of environmental monitoring, sterilization and microbial support in medical devices industry preferred
248
Microbiologist Resume Examples & Samples
- Perform various Microbiological testing procedures per batch records, raw material requests for testing and stability protocols
- Prepare reagents, samples for analyses
- Cleaning the lab and equipment
- Perform environmental monitoring during the manufacturing operations
249
Senior Microbiologist Resume Examples & Samples
- Provide ENT and other Medtronic business units expertise on microbial, sterilization, and clean-area environmental matters that is current state of technical and regulatory expectations
- Manage the activities of the Quality Services group, including, but not limited to, developing strategies, priorities, planning, directing implementation & maintaining costs, methods & staffing
- Ensure all quality initiatives and standards, including ISO procedures are maintained and compliant throughout all aspects of operations
- Oversee the performance of functional group to assure that products and processes meet regulatory requirements. Review and approve validation protocols and reports to support change controls. Monitor validated states for sterilization processes including, but not limited to ETO, Gamma, E-Beam, Gas Plasma, or Steam
- Implement sterilization validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements. Interface, on an as needed basis, with regulatory agencies in conjunction with routine audits, field complaint investigations and technical interchanges
- Implement clean room and processed water programs to establish and maintain a satisfactory level of compliance with regulatory requirements
- Manage Corrective Action Preventive Action (CAPA) initiatives
- Provide technical support to R&D for new product development
- Provide leadership in the design, specification and selection of sterilization equipment. Evaluate alternatives, propose and recommend solutions to problems. Assess and update sterilization strategies for strengths, weaknesses, opportunities, and threats
- Establish standards for Environmental Monitoring and Trending for clean rooms and water system
- Ensure a highly trained and effectively performing work group. Prepare and maintain annual budgets.All activities must be performed in compliance with the Quality System
- Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
- Travel requirement: Less than 10%
- Bachelor’s degree in microbiology, biology, or related discipline
- 7+ years of experience in medical device or pharmaceutical sterilization technologies with a Bachelor’s
- 5+ years of experience in medical device or pharmaceutical sterilization technologies with a Masters
- 5+ years of leadership/managerial experience
- No specialized knowledge required
- 15 + years of experience in medical device or pharmaceutical sterilization technologies with a Bachelor’s
- 12+ years of experience in medical device or pharmaceutical sterilization technologies with a Masters
- Proficiency in critical systems such as clean room and processed water design and requirements
- Effective budgeting skills
- Problems solving and decision making skills
- Ability to effectively communicate at all levels and across the organization
- Performance Management Leadership and staff development skills
- Demonstrate appropriate leadership skills and styles in varying circumstances
- Effectively bring together various individuals and departments for common effort
- Well-developed computer skills with expertise in Word, Excel, PowerPoint & statistical tools
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers
- During the course of regular assigned duties, the employee may be required to properly utilize personal protective equipment including but not limited to: safety shoes, safety glasses, goggles, hard hats, air purifying respirator or supplied air respiratory protection
- The employee must be able to lift 10 pounds per job requirement
250
MT Microbiologist Resume Examples & Samples
- Prepare, read and interpret gram stains
- Plate patient samples on required culture media by specimen source
- Setup and interpret confirmation testing as appropriate
- Perform aerobic, anaerobic, and fungal cultures
- Workup samples for the presence of parasites
- Perform rapid PCR testing for C-Diff and MRSA
- Run and interpret antibiograms for isolated pathogens
- Call tests results considered critical
- Run quality control and pass all government mandatory proficiency testing
- Perform instrument maintenance and troubleshooting
- Provide physician consultation on complex cultures
- Work with the infectious disease specialists
- Follow safety protocols to protect against avoidable exposure to pathogens by using the biologic hoods and other safety equipment as designed for the microbiology laboratory