Quality Control Microbiologist Resume Samples
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Quality Control Microbiologist Resume Samples
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FK
F Kohler
Florian
Kohler
21460 Ezra Trace
Philadelphia
PA
+1 (555) 170 4348
21460 Ezra Trace
Philadelphia
PA
Phone
p
+1 (555) 170 4348
Experience
Experience
Phoenix, AZ
Quality Control Microbiologist
Phoenix, AZ
Osinski Group
Phoenix, AZ
Quality Control Microbiologist
- Demonstrated proficiency in Aseptic Process Environmental Monitoring, Aseptic Testing, Microbial Monitoring, Gram Staining, Sub-culturing, Bacterial Endotoxin Testing, Bioburden Testing, TOC, Plating, Membrane Filtration, and other USP testing
- Coordinate with Manager and other team members in organizing workload as to ensure timely release of all testing
- Troubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer’s technical services to resolve issues
- Perform accurate and timely sterility testing per procedure and report results per cGMP/GLP Guidelines
- Perform other duties as assigned
- Schedule and perform QC activities in Blue Mountain RAM platform
- Perform in-house microbiological assays, water, and steam attribute testing and other sampling procedures
Phoenix, AZ
Quality Control Microbiologist, nd Shift
Phoenix, AZ
Cummings Inc
Phoenix, AZ
Quality Control Microbiologist, nd Shift
- Perform microbiological testing (endotoxin, bioburden) for water
- 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)
- Perform line clear and line start verifications
- Perform microbial characterization (gram stain, catalase, oxidase, and couagulase tests)
- Perform other microbiological assays
- Maintain historical files on organisms found in classified areas; microbial identification and trending
present
San Francisco, CA
Senior Quality Control Microbiologist
San Francisco, CA
Spencer-Ziemann
present
San Francisco, CA
Senior Quality Control Microbiologist
present
- Perform analytical testing as a main priority with efficiency and accuracy
- May provide technical guidance
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
- Write protocols and perform assay validation and equipment qualification/verification
- Report, evaluate, back-up/archive, trend and approve analytical data
- Initiate and/or implement changes in controlled documents
Education
Education
Bachelor’s Degree in Microbiology
Bachelor’s Degree in Microbiology
Pepperdine University
Bachelor’s Degree in Microbiology
Skills
Skills
- Excellent verbal and written communication skills Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
- Escalate issues professionally and on a timely basis
- Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Negotiation and Influence skills
- Problem solving skills
- Teamwork and Coaching others
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
4 Quality Control Microbiologist resume templates
Read our complete resume writing guides
1
Senior Quality Control Microbiologist Resume Examples & Samples
- Bachelor's degree in a science discipline
- Biopharmaceutical QC experience in a microbiology lab
- 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
- Take initiative to identify and drive improvements
- Excellent verbal and written communication skills Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Escalate issues professionally and on a timely basis
- Teamwork and Coaching others
- Negotiation and Influence skills
- Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
2
Associate Microbiologist Quality Control Resume Examples & Samples
- Execute laboratory work, schedule with input from supervisor or senior team member
- Drafts technical documents such as SOPs, COAs and protocols with direct supervision
- Perform parallel review of laboratory documents, may perform technical review of documents such as protocols, specifications, etc
- Perform parallel review, verification of actions and transcription
- Trains, coaches or mentors on technical issues. Trains others on laboratory techniques
- Executes Operational Excellence/efficiency projects with guidance
- Bachelor’s Degree w/ 5+ years experience
- Master’s Degree w/ 2+ years experience
3
Quality Control Associate Microbiologist Resume Examples & Samples
- Test products as scheduled in an efficient and timely manner per procedures and specifications
- Trouble shoot performance testing issues with the help of management and coworkers. Only forward lots to Industrialization after investigation into performance testing issues have been completed. Perform failure analysis at a level to determine preliminary cause of problem
- Support product and process improvements
- Support special projects as directed by management
- Certified in organism subculture, and setting up reagents for performance testing
- Update QC Database with lot status each day, and file Quality records routinely
- Support Environmental Monitoring
- Certified in Device History Review and Base Broth Book Reviews for GMP compliance per procedures and regulations
- Take ownership of a product line for shelf life testing
- Certified with Trackwise and initiate Nonconforming Material Reports (NCMR’s) and Nonconformance (NC’s)
- Temporary modification to provide reasonable accommodations do not waive any essential functions of the job requirements
- Reasonable, reliable attendance and punctuality is an essential job function required for this position
- Must have a 4 year scientific college degree or equivalent
- Experience in a microbiology lab is preferred
- Provide technical review of QC data
- Identify adverse trends and propose corrective actions
- Knowledge of GMP compliance
- Provide accurate, timely and reliable information and reports
- Adhere & enforce bioMérieux quality policies and procedures
- Support global quality initiatives
- Knowledge of quality risk assessments and quality policies and procedures
- Assist management to identify and mitigate gaps in quality systems
4
Quality Control Microbiologist, nd Shift Resume Examples & Samples
- Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
- Strong organizational skills and the ability to prioritize/multitask
- Proficient in Microsoft Office Suite (excel)
5
Quality Control Microbiologist Resume Examples & Samples
- Perform accurate and timely sterility testing per procedure and report results per cGMP/GLP Guidelines
- Support all manufacturing and validation operations; including but not limited to process validation, environmental monitoring, and utility systems
- Perform in-house microbiological assays, water, and steam attribute testing and other sampling procedures
- Prepare analytical reports, trend analysis reports or yearly summaries as required
- In a timely fashion, review, and release of microbiological test results as to ensure compliance with standard operating procedures
- Oversee daily activities in the absence of the supervisor/manager
- Troubleshoot instrument problems and work with the lab supervisor/manager and equipment manufacturer’s technical services to resolve issues
- Perform instrument maintenance and calibration verification/standardization as required
- Schedule and perform QC activities in Blue Mountain RAM platform
- Initiate, investigate and write deviations, change controls, out of specification (OOS), out of trend (OOT)
- Write, revise, and review standard operating procedures (SOPs) applicable to QC operations
- Support domestic and international regulatory agency inspections
- Mentor Microbiology staff on compendia, instrument operations, maintenance and test methods per SOPs, and agency regulations as needed
- Coordinate with Manager and other team members in organizing workload as to ensure timely release of all testing
- Must be able to work as part of a team and also independently with minimum supervision
- Travel required to various local United Therapeutics facilities as necessary for assigned projects
- Knowledge and understanding of cGMPs, USP, EP, JP, FDA, and other regulatory requirements
- Experience working with LIMS systems
6
Quality Control 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
- Gather metric information for use in continuous improvement of areas of responsibility
