Associate, Quality Control Resume Samples
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Associate, Quality Control Resume Samples
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AH
A Hills
Aleen
Hills
24758 Rhett Plain
Detroit
MI
+1 (555) 836 6246
24758 Rhett Plain
Detroit
MI
Phone
p
+1 (555) 836 6246
Experience
Experience
New York, NY
Associate, Quality Control
New York, NY
Sawayn, DuBuque and Gibson
New York, NY
Associate, Quality Control
- Coordinates QC support activities & projects related to instrumentation with other departments; provides updates to team and QC supervisor. Works closely with QA , validation, facilities, I&C, Unity, vendors etc. Supports and helps to assure effective laboratory systems/life cycle to ensure integrity of all laboratory instrumentation/equipment programs. Can participate in a lead role for site cross-functional teams as a representative of the QC laboratory, including audit & inspections
- Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to: Total Organic Carbon/Conductivity/Nitrates, Bioburden/Endotoxin, Titrimetry, pH/Osmolality, Sampling and inspection methodologies
- Troubleshooting and investigation of sample management issues
- Conducts and supports maintenance of laboratory equipment through execution and oversight, coordination of weekly, monthly, quarterly and annual PM execution for QC labs. Utilizes systems for monitoring equipment status and Preventative and corrective maintenance closure
- Supports the plan, implements core functions of team related to equipment/instrument maintenance and projects; provides technical
- Through GCC and activity execution; where necessary. Contributes to overall RAR’s, work order, PM’s, system optimization efforts, projects
- Subject matter expert in regards to Raw Material testing and equipment used for both Chemistry and Microbiology testing of the raw materials. Will support the management team for the direction of testing, compliance and overall lab activities
Phoenix, AZ
Senior Associate Quality Control
Phoenix, AZ
Leuschke-Pfannerstill
Phoenix, AZ
Senior Associate Quality Control
- Collaborate with Analytical Development, provide input and review method development and validation studies
- Perform general housekeeping in all sample management areas
- Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis
- Responsible for providing relevant QC documents to Management
- Perform routine sample management tasks as per procedures
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
- Manage reference standards program for commercial products
present
San Francisco, CA
Senior Associate, Quality Control
San Francisco, CA
Barrows and Sons
present
San Francisco, CA
Senior Associate, Quality Control
present
- Supports the team related to equipment/instrument purchase, maintenance, and implementation or decommissioning projects; provides technical support as well as facilitation of investigations/compliance tasks; supports QC staff and lab operations related to business; supports global harmonization initiatives; training and completion of projects to milestones
- Addresses requests for Quality related documentation (is… CoA’s, Certification for absence of product/process impurities) to support submission and approval of regulatory filings and responses to agency queries for drug substance and drug product for all regulatory agencies, US, EU and ROW as assigned by PQM management with limited supervision
- Plans, implements and directs core functions of teams related to equipment/instrument purchase, maintenance, and implementation or decommissioning projects; provides technical support as well as facilitation of investigations/compliance tasks; supports QC staff and lab operations related to business; supports global harmonization initiatives; training and completion of projects to milestones
- Coordinates QC support activities/projects related to instrumentation/equipment with other departments & key contacts (internally/externally); provides updates to QC management. Works closely with QA, IT, facilities, etc. Supports and helps to design effective laboratory systems/life cycle to ensure integrity of all laboratory instrumentation/equipment programs. Participates in a leadership or membership role for site cross-functional teams as a representative of the QC laboratories
- Support the definition and implementation of more efficient processes around LIMS/ELN change management
- Evaluation, scheduling, and balancing of departmental workload with respect to sample management assignments
- Assists in developing and qualifying analytical and/or microbiological methods with frequent supervision
Education
Education
Bachelor’s Degree in Biological Science
Bachelor’s Degree in Biological Science
The University of Texas at Austin
Bachelor’s Degree in Biological Science
Skills
Skills
- Two (2) to four (4) years’ experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment, and with emphasis in aseptic processing, clean room operations, environmental monitoring, and/or validation and manufacturing processes
- Authors alert actions, CAPAs, deviations and laboratory exceptions, investigational protocols, investigational reports, change control requests, and Quality Technical Reports, perform Certificate of Analysis issuance according to applicable procedures. etc
- Conducts and supports maintenance of laboratory equipment through execution and oversight, coordination of weekly, monthly, quarterly and annual PM execution for QC labs. Utilizes systems for monitoring equipment status and Preventative and corrective maintenance closure
- Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group
- Performs final review for analytical data to support facility monitoring and/or drug substance and drug product routine testing and characterization and attends and participates in relevant meetings
- Leads, authors and reviews AIV (IOPQ), decommissioning protocols, other instrument/equipment related protocols, technical reports, and change control requests, as applicable. Ensures compliance with platform, procedures and global QC vision
- Two (2) to four (4) years’ experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment, and with emphasis in analytical testing, method transfer, and/or method validation
- Coordinates QC support activities & projects related to instrumentation with other departments; provides updates to team and QC supervisor. Works closely with QA , validation, facilities, I&C, Unity, vendors etc. Supports and helps to assure effective laboratory systems/life cycle to ensure integrity of all laboratory instrumentation/equipment programs. Can participate in a lead role for site cross-functional teams as a representative of the QC laboratory, including audit & inspections
- Ability to flex and respond to unexpected situations/demands; effectively problem solve and raise issues appropriately, as well as provide resolution as necessary. Supports tracking of tasks and departmental metrics
- Proficiency with multi-channel pipets
15 Associate, Quality Control resume templates
Read our complete resume writing guides
1
Associate, Quality Control Resume Examples & Samples
- Investigates discrepancies and captures activities in writing and ensures appropriate corrective actions captured as applicable for laboratory exceptions, OOS, AR and systematic IA. Authors deviations, environmental excursions, initiates planned exceptions, CAPA, and sees them through to completion. Proficient in compliance and quality operations and can execute change controls, planned exceptions
- Initiates and monitors QC laboratory documentation, such as Standard Operating Procedures, methods and periodic review of laboratory procedures. Generates metrics report for management review
- Review documentation for accuracy, quality and compliance. Support laboratory operations and actively communicates across functional groups for completion of deliverables
- Identify improvement opportunities and effect strategies for site/departmental implementation. Team oriented. Drives change and supports implementation of change
- Good working knowledge of operations/quality systems understands work processes of QC operations/support teams (eg; strong test method/scientific base)
- Completes deliverables, able to draw conclusions from data interpretation
- Solid technical writing skills, authors reports with input & guidance and conducts compliance/work impact assessments as appropriate
- Participates in process improvements, supports management & QC teams
- Contributes toward overall objectives; occasionally contributes toward decision making; works across teams
- Identifies and troubleshoots technical/operational problems, and works with manager to understand and implement solutions
- Plans and executes work independently uses discretion and experience to resolve problems or issues
2
Associate, Quality Control Resume Examples & Samples
- Coordinate, organize, prioritize and perform compendial raw material testing and hereto related activities such as operating in IT systems, documentation, document review and trouble shooting. Including review of sampling documentation. Ad hoc testing including buying and tracking chemicals
- Responsible as a team member for QC Materials projects incl assist with implementation of new technologies, processes and systems within the area
- Other job duties that may be assigned from time to time
3
Master Associate, Quality Control Resume Examples & Samples
- Maintains and updates QC LIMS. Ensures all project testing and sampling is created in LIMS prior to start of GMP production. Creates and revises sample and testing reports. Schedules and provides training to end-users. Ensures testing and release time lines are met. Follows well-defined and established procedures and best practices. Reviews QC test results. Participates in the global implementation of new LIMS software
- Prepares sample reconciliation reports and other reports as needed. Creates LIMS system documentation such as SOP’s, Installation and User Manuals and Training Materials
- Assists with QC's data management, including data compilation and review, protocol generation, collates and organizes raw data and result reporting
- Works with end users in QC and Mfg to create reports and update LIMS to provide LIMS outputs that make it more user friendly and efficient
- Participate in deviation investigation and processing of change control records
- QC representative on client internal project teams
- Demonstrate troubleshooting and critical thinking skills. Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet time lines
- Interface with other functional groups within and outside QC to request/share information, provide results and coordinate testing
4
Senior Associate, Quality Control Chemistry Resume Examples & Samples
- Analytical Testing
- Under minimal supervision, performs testing, conducts lab investigations, problem-solves, provides supervision of product testing and reports aberrant results to management
- Under minimal supervision, performs required cell and/or reagents qualifications
- Performs Quality Control Biochemistry Testing Group (eg., HPLC, CE, PCR, Bioassay, ELISA, Raw Material, and Physico-Chemical)in a timely manner. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner
- Documentation
- Generates, reviews and/or maintains records or documents in a detailed and consistent manner
- Ensure all equipment use logs are recorded for assays performed
- Assists with QC's data management, including data review, assay monitoring (e.g., invalid test log and control chart log)
- Process improvement and compliance
- Coordinates and manages continuous improvement projects
- Revises standard operating procedures, training manuals, etc. which are submitted to management for adjustments and final approval
- Maintains specific QC files and database records for process and/or quality improvement efforts
- Actively support cross functional teams and share information, as appropriate, with colleagues. Effectively communicate with supervisors, colleagues and/or managers in other departments and sites. Participate in method validation and method transfer activities
- Demonstrate troubleshooting and critical thinking skills. Highly productive, attention to detail, ability to manage own time and prioritize tasks independently to meet time lines. Maintain laboratory cleanliness and orderliness. Dispose expired chemicals timely, ensure all equipment is within calibration and/or qualification dates and resolve any malfunction issues through appropriate SOPs
- Ensure that training is up-to-date and other personal development programs are in place
5
Associate, Quality Control Resume Examples & Samples
- Analytical testing
- Two (2) to four (4) years’ experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment, and with emphasis in aseptic processing, clean room operations, environmental monitoring, and/or validation and manufacturing processes
- Experience with LIMS or with off-the-shelf laboratory automation systems
- Experience in performing investigations related to biopharmaceutical quality issues is preferred
6
Laboratory Associate, Quality Control Resume Examples & Samples
- Execute laboratory work, schedule developed by supervisor or senior team member
- Data entry from raw data forms, document revisions with oversight
- Perform parallel review of laboratory documentation, may perform technical review of documents such as protocols, specifications, etc
- Train other on laboratory techniques
- May draft technical documents such as SOPs with direct supervision
- Participate in assigned duties to support operational excellence projects with oversight
- Associate’s Degree w/2 + years experience
- Bachelor’s Degree w/ no previous experience
7
Research Associate, Quality Control Resume Examples & Samples
- Conducts both routine and non-routine analysis of raw materials and manufactured samples
- Performs cleaning verification analysis of manufacturing equipment
- Develops and applies knowledge of site procedures (SOPs)
- Develops and applies knowledge of Good Manufacturing Practices (GMPs) [e.g. ICH Q7]
- Reviews analytical data to ensure accuracy and conformance to SOPs
- Attends all group meetings and staff training sessions. Contributes when required
- Suggests improvements to laboratory test methods, procedures when noted
- Routinely uses software such as Empower, LIMS, MS Word, MS Excel
- Participates in weekly laboratory clean-up
- Entry level for BS, MS degree with no experience
- AA degree plus some lab experience
8
Production Associate, Quality Control Resume Examples & Samples
- RNA extraction
- RT-PCR and cDNA purification
- Adherent cell culture
- Cytopathic effect assays
- Reports quality results to supervisor in a timely manner
- Excellent communication skills; able to interpret and communicate results effectively to superiors
- Working knowledge of laboratory equipment such as autoclaves, biosafety cabinets, laminar flow hoods, fluorescence microscopes, and PCR
- Working knowledge and experience in PCR techniques
9
Associate, Quality Control Resume Examples & Samples
- Conducts and supports maintenance of laboratory equipment through execution and oversight, coordination of weekly, monthly, quarterly and annual PM execution for QC labs. Utilizes systems for monitoring equipment status and Preventative and corrective maintenance closure
- Supports the plan, implements core functions of team related to equipment/instrument maintenance and projects; provides technical
- Support as well as facilitation of RAR tasks; supports QC supervisors and lab operations related to business; support of validation initiatives
- Through GCC and activity execution; where necessary. Contributes to overall RAR’s, work order, PM’s, system optimization efforts, projects
- & training for team
- Coordinates QC support activities & projects related to instrumentation with other departments; provides updates to team and QC supervisor. Works closely with QA , validation, facilities, I&C, Unity, vendors etc. Supports and helps to assure effective laboratory systems/life cycle to ensure integrity of all laboratory instrumentation/equipment programs. Can participate in a lead role for site cross-functional teams as a representative of the QC laboratory, including audit & inspections
- Ability to flex and respond to unexpected situations/demands; effectively problem solve and raise issues appropriately, as well as provide resolution as necessary. Supports tracking of tasks and departmental metrics
- Leads, authors and reviews AIV (IOPQ), decommissioning protocols, other instrument/equipment related protocols, technical reports, and change control requests, as applicable. Ensures compliance with platform, procedures and global QC vision
- Demonstrated leadership abilities, strong presentation, oral and written communication skills
- Ability to coordinate multiple activities in parallel, demonstrated problem solving skills,
- Demonstrated instrument/method troubleshooting skills,
- Knowledge of USP/FDA/EMA, ICH regulations and compliance
- Broad knowledge of operations/quality systems/directives,
- Excellent technical writing skills; authors technically-sound simple to moderately complex reports with limited guidance
- Proficient in their understanding of the quality systems and applies that knowledge within the team/project management routinely
10
Senior Associate Quality Control Resume Examples & Samples
- Executing against robust quality assurance programs for volume-based operational processes and/or controls that are managed directly by AML Compliance Management while adhering to Company Standards for Business Unit Testing and Monitoring
- Attending continuing education courses
- 3 years work experience
- Quality Control work experience
11
Associate, Quality Control Resume Examples & Samples
- Two (2) to four (4) years’ experience in QC within the Pharmaceutical or Biotech industry, in a GMP or GLP regulated laboratory environment, and with emphasis in analytical testing, method transfer, and/or method validation
- Culture of mammalian cells
- Proficiency with multi-channel pipets
12
Associate, Quality Control Resume Examples & Samples
- Performs and documents routine environmental monitoring, routine testing and characterization activities, as needed
- Performs final review for analytical data to support facility monitoring and/or drug substance and drug product routine testing and characterization and attends and participates in relevant meetings
- Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group
- Authors alert actions, CAPAs, deviations and laboratory exceptions, investigational protocols, investigational reports, change control requests, and Quality Technical Reports, perform Certificate of Analysis issuance according to applicable procedures. etc
- Participates effectively in a membership role for site cross-functional teams as a representative of the QC Laboratory
- Provides Leadership through effective project management and mentoring as needed
- Demonstrated technical abilities, solid presentation, oral and written communication skills
- Ability to communicate with peers and management
- Solid understanding of biological science principles
- Demonstrated instrument/method troubleshooting and problem solving skills
13
Associate, Quality Control Chemistry Resume Examples & Samples
- On a daily basis, perform the in-process and release analysis on clinical and release product related samples. Perform advanced trouble shooting techniques on assays, test and laboratory equipment when needed
- Train staff in laboratory techniques at all levels of complexity. Take responsibility for own training
- Other job duties that may be assigned from time to time, which could include cross-functional collaborative and project team leadership assignments, consistent with personal strategic, operational and technical leadership
- Minimum 5 years of experience as a laboratory technician, or equivalent position
- Ability to work in a team and as an individual
- A good understanding of GMP/ GLP guidelines
- Ability to plan, prioritize and to complete own work
14
Senior Associate Quality Control Resume Examples & Samples
- Oversee commercial product testing, including coordination of testing with contract testing laboratories, review of testing data, issuance of Certificate of Analysis
- Quality Liaison with external contract laboratories used for testing of commercial products
- Act as primary liaison with marketing partners for management of corresponding Quality responsibilities and timely submission of CMC records
- Manage stability studies: monitor sample pull schedule at contract laboratories, author or review stability documentation
- Conduct release and stability data trending
- Manage reference standards program for commercial products
- Collaborate with Analytical Development, provide input and review method development and validation studies
- Oversee conduct of out-of-specification investigations at contract laboratories
- Author CMC sections related to batch analyses, specifications, stability, raw materials, environmental monitoring, etc. in NDA, BLA (including annual reports and amendments)
- Bachelor’s degree or higher in Life Sciences, Chemistry, Biology, or related field with minimum of 8 years of Quality Control experience in pharmaceutical/biotechnology industry
- Experience with data trending is required
- Experience with biological products is preferred
- Experience interfacing directly with the FDA, and other regulatory agencies is preferred
- Must possess a thorough knowledge of GMP guidelines and regulations, ICH guidelines, and regulatory compliance related to Laboratory Control system
- Proficiency with statistical analysis is required
- Effective communication skills; proven record with successful collaboration in a global business environment
- Ability to prioritize and successfully manage complex and competing projects
15
Associate, Quality Control Resume Examples & Samples
- Understanding of basic biological science principles
- Developing or demonstrated instrument/method troubleshooting and problem solving skills
- General knowledge of FDA/EMEA regulations and compliance
16
Senior Associate Quality Control Resume Examples & Samples
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Experience in a wide variety of analytical techniques including but not limited to Capillary Electrophoresis, Gels or HPLC
17
Associate, Quality Control Resume Examples & Samples
- Identifies areas needed procedural and/or policy changes, and make recommendations to management. Assist with implementation of new technologies, processes and systems within the laboratory
- From time to time, review release data packages, writing investigation reports, control and reference qualification reports etc
- Buying, tracking chemicals and on ad hoc basis setting up new equipment in the lab
18
Senior Associate, Quality Control Resume Examples & Samples
- Accurately performs analytical and/or microbiological testing following SOPs
- Assists in developing and qualifying analytical and/or microbiological methods with frequent supervision
- Reviews and verifies analytical and/or microbiological data and reports ensuring accuracy and consistency
- Accurately ships samples to clients and fills out appropriate paperwork
- Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc
- Accurately completes routine and preventative maintenance on laboratory equipment
- Actively participates in team meetings
- Experience operating, maintaining, and troubleshooting sequencing techniques
- Mammalian cell culture experience is preferred
- Preferred – HPLC, SDS-PAGE, Western Blot, HPLC, cIEF and ELISA experience, and/or Microbiology testing
- CGMP documentation practices
- Experience writing standard operating procedures
- General laboratory equipment experience, including micropipettes
19
Senior Associate, Quality Control Resume Examples & Samples
- Subject matter expert in regards to Raw Material testing and equipment used for both Chemistry and Microbiology testing of the raw materials. Will support the management team for the direction of testing, compliance and overall lab activities
- Support and lead validation/qualification projects for QC Raw Materials laboratory equipment and instruments per applicable procedures. Supports preventative maintenance of equipment/instruments and provides updates to management for project status
- Authors qualification protocols and reports and ensures testing is completed on time to support creation of the new or revised item specification
- Assist and plans training for team and supports completion of projects to milestones
- Supports the team related to equipment/instrument purchase, maintenance, and implementation or decommissioning projects; provides technical support as well as facilitation of investigations/compliance tasks; supports QC staff and lab operations related to business; supports global harmonization initiatives; training and completion of projects to milestones
- Possess technical knowledge regarding QC analytical testing and instrument systems, lab methodology (as appropriate)
- Strong organizational and project management skills
- Ability to coordinate multiple activities in parallel
- Knowledge of FDA/EMA/PMDA regulations including 21CFR parts 210/211 (GMP), EudraLex Vol. 4 (EU GMP), Annex 8
20
Senior Associate, Quality Control Resume Examples & Samples
- Reviewing and approving product CoA’s and In process Result Summary Reports
- Proactively identify technical gaps and areas for improvement related to quality or process and leads them through completion, can represent in internal and external audit proficiently
- Leading and Supporting Departmental, Cross-Functional, and Global projects,
- Assessing and Completing Global Change Controls that impact QC Sample Control
- Evaluation, scheduling, and balancing of departmental workload with respect to sample management assignments
- Adherence to all regulatory licenses and regulations,
- Interfacing with key Quality and manufacturing customers, and
- Coordination of investigations impacting the QC department
- Demonstrated leadership abilities in a GMP environment
- Demonstrated computer skills with an emphasis on LIMS and paperless sample management
- Ability to communicate with management and peers effectively
- Ability to multi-task and coordinate multiple activities in parallel
- Knowledge of FDA/EMEA regulations and compliance
- * The QC sample Control group supports manufacturing and QC operations 7 days a week. ***
- * This position will support some weekend work and some holiday support. ***
21
Associate, Quality Control Resume Examples & Samples
- Authors protocols, change control requests, and Quality Technical Reports, as directed etc
- Provides timely review/corrections for data and documentation generated for or by QC
- Participates in the execution of method transfer, method development, method qualification, analytical improvement projects, reagent qualification/extension, and validation of analytical methods in collaboration with teams as appropriate
- Understanding of basic scientific principle, ability to communicate with peers and management; GMP/GDP experience
- Developing problem solving skills
- Developing technical, instrument/method troubleshooting skills in bioassays and potency testing for biologics
- Good working knowledge of operations/quality systems utilized in QC operations/support teams (eg; test method/scientific base)
- Solid technical writing skills
22
Senior Associate, Quality Control Resume Examples & Samples
- Coordinates/performs testing and review for analytical data to support clinical and validation activities. Provides troubleshooting support for instruments/complex problems and manages non complex issues, barriers, problems to support team success. May approve data, reports for team, area of discipline/focus.
- Authors protocols, change control requests, and Quality Technical Reports for ensuring successful execution of method transfer, qualification, analytical improvement projects, in collaboration with teams as appropriate. Provides technical leadership through effective project management, status tracking, presentations, and communication
- Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the laboratory. Actively provides leadership and mentoring as needed to aide in the development of team/peers, self and team projects
- Proactively identifies technical gaps and areas for improvement related to quality or process and leads them through completion, can represent in internal and external audit proficiently
- In-depth knowledge of laboratory operations, quality systems, validation; technical expertise in bioassays and potency testing for biologics (Fret, Alpha-Screen, proliferation assays, ELISA, cell-based assays)
- Excellent technical writing/presentation/communication skills
- Experience approving complex reports, data of others, as well as leading complex problem solving through facilitation/escalation
- Understanding of impact to project and or team (includes impact to validation data as relates to job function within QC)
- Mature leadership approach and understanding of their personal communication style and manage that effectively
- Mentors junior members of team in quality systems, process improvements
- Leadership competencies include follow up, decision making, communication, collaboration, and innovation
23
Associate, Quality Control Resume Examples & Samples
- In-depth knowledge of laboratory operations, quality systems, validation; technical expertise in biochemistry methods (HPLC/UPLC, CE, icIEF, UV-Vis, etc.)
- Experience authoring and reviewing complex reports, data of others, as well as leading complex problem solving through facilitation/escalation
- The ability to formulate solutions/options for team and align externally with regulatory/global teams/sites
- Understanding of their personal communication style and manage that effectively
- Assists in setting/reporting measurable goals & targets and mitigation plans, as appropriate
24
Senior Associate Quality Control Lims Resume Examples & Samples
- Provide Laboratory IS administration and implementation and technical support services for SM- LIMS, Accelrys Smartlab (LMES) and Accelrys CIMS (Inventory Management), EMpower
- Build, develop and maintain LIMS templates, LMES eProcedures, CIMS templates
- Evaluate new or revised eProcedures in conjunction with lab SMEs
- Provide support for eProcedure implementation e.g. LMES method info, method trending info, SOP updates
- Troubleshoot laboratory methods in LIMS and resolve issues
- Review and Approval of Quality Documentation e.g. Sample Plans, Forms, SOPS
- Contribute to Computer System Validation activities within the QC laboratory
- Facilitate IT projects within Amgen such as network upgrades, disaster recovery and migration activities
- Develop training documentation and SOP’s for laboratory LIMS/ LMES/ CIMS requirements in adherence to Amgen requirements, SOP’s, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems
- Manage and implement projects to maintain, develop and support Lean Laboratory practices such as review by exception, paperless lab systems etc
- Ensures the system’s application user operations procedures are accurate, effective and being followed for the application, user responsibilities, user roles, access privileges and training requirements per role
- Partner with the global Master Data Group as needed
- Manage and support any additional QC IS projects as required
- Represents QC on global level topics related to LIMS/ LMES/CIMS/ EMpower and QC IS Solutions
- Provide Instructor led training for QC IS systems
- Support for Password administration and session unlocking
- Audit and Inspection preparation and participation
- Evaluate system practices for compliance and operational excellence improvement on a continuous basis
- Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment with previous experience as a user (as a minimum) for LIMS/LMES/CIMS/ Empower or administration experience
- Familiar with (or can learn) new laboratory information systems and can self-teach technical topics
- Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP
- Knowledge on Data Integrity Assessments (DIA) for computerised systems and execution of CFR 21 Part 11 for computerised systems
- Excellent Organisational Skills and Time Management
- Ability to work under minimal supervision
25
Associate Quality Control Resume Examples & Samples
- Degree in life sciences or other scientific field and 1 + years of Lab experience in life sciences
- 1 + years of experience in a regulated GMP or GLP environment
- Ability to facilitate and influence clients and partners
- Ability to successfully manage workload to timelines
- Ability to operate specialized equipment and computers as appropriate to the individual area, and understand, apply, and evaluate basic chemistry, biology, microbiology, physical, and mathematical principles
26
Associate, Quality Control Resume Examples & Samples
- Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to: Total Organic Carbon/Conductivity/Nitrates, Bioburden/Endotoxin, Titrimetry, pH/Osmolality, Sampling and inspection methodologies
- Provides timely corrections for data and documentation generated for or by QC
- Participates in the execution of method/material qualification and analytical improvement projects
27
Associate, Quality Control Resume Examples & Samples
- Strong background working with bioassays such as ELISAs, cell-based bioassays, AlphaScreen methods, MSD Multiplex, and Delfia assays is preferred
- Authors protocols, change control requests, and Quality Technical Reports, as directed/needed etc
- Provides technical leadership as a subject matter expert in one or more disciplines
- Demonstrate problem solving skills
- Demonstrate technical, instrument/method troubleshooting skills in bioassays and potency testing for biologics (ELISA, cell- based assays, etc.)
- Possess a solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g.; strong test method/scientific base)
- Possess strong technical writing skills
28
Senior Associate, Quality Control Resume Examples & Samples
- Leads validation/qualification projects for QC laboratory equipment, instruments, software applications and computer systems per applicable procedures. Authors, executes and reviews system life cycle documentation including VP, RS, IOPQ protocols, decommissioning protocols, other compliance related protocols/reports, change control requests, validation protocols/reports as applicable. Ensures compliance with platform, procedures and Global QC vision. Assist and plans training for team and supports completion of projects to milestones
- Plans, implements and directs core functions of teams related to equipment/instrument purchase, maintenance, and implementation or decommissioning projects; provides technical support as well as facilitation of investigations/compliance tasks; supports QC staff and lab operations related to business; supports global harmonization initiatives; training and completion of projects to milestones
- Coordinates QC support activities/projects related to instrumentation/equipment with other departments & key contacts (internally/externally); provides updates to QC management. Works closely with QA, IT, facilities, etc. Supports and helps to design effective laboratory systems/life cycle to ensure integrity of all laboratory instrumentation/equipment programs. Participates in a leadership or membership role for site cross-functional teams as a representative of the QC laboratories
- Possess technical knowledge regarding QC analytical equipment and instrument systems, lab methodology (as appropriate)
- Demonstrated strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively
- Demonstrated instrument/computer system troubleshooting skills
- Knowledge of FDA/EMEA regulations including 21CFR parts 210/211 (GMP), EudraLex Vol. 4 (EU GMP), 21CFR Part 11, Annex 11
- Working knowledge of GAMP 5 for GxP Computerized Systems and/or USP Analytical Instrument Qualification
- Skilled in validation lifecycle (CSV, SDLC) documentation creation and review, including: GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design Specifications, IQ/OQ/PQ Protocols, Reports, and Standard Operating Procedures (SOPs)
- Experience with managing the periodic and preventative maintenance of equipment/instruments and maintaining the validated state of analytical equipment and instruments through change control and regularly scheduled periodic review
29
Associate Quality Control Reviewer Resume Examples & Samples
- Evaluates laboratory data for compliance with analytical methods and SOPs
- Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings
- Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction
- Communicates with laboratory staff to proactively address the quality of laboratory documentation. Consults with supervisor regarding priority of assignments
- BS in Science or related field required
- 0-2 years of QA/QC experience; 1-2 years preferred
- Or an equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Knowledge of chromatography and divisional SOPs
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Senior Associate, Quality Control Resume Examples & Samples
- Collaborate with business subject matter experts to define and document new or revised LabWare requirements
- Lead the design and development of new or revised LabWare LIMS and ELN objects to support the business and functional requirements
- Configuration of basic and advanced LabWare objects including, but not limited to: Specifications, Analyses, Batch Templates, Calculations, Format Calculations, Subroutines, Code Snippets, Parsing Scripts, Visual Workflows, and Various Templates (ELN Experiments, ELN Experiment Workbooks, Stability, Sample Login, Standards and Reagents)
- Configuration of new instrument interfaces to LabWare LIMS
- Draft necessary requirement and qualification (IQ, OQ, UAT) documentation
- Execute qualification or verification testing to support final implementation of LabWare configuration additions/revisions
- Author or revise procedures governing QC administration of the LabWare LIMS/ELN system
- Maintain and, if necessary, repair all existing configuration objects within Labware LIMS/ELN
- Assist the Labware business owner and QC LIMS Support Team Lead in prioritizing the workload for LIMS related projects
- Creates queries to support business requirements
- Be able to understand QC procedures with regard to data collection, data analysis, data evaluation, data transfer, and LIMS/ELN operations
- Provides training to new and current employees as needed
- Stay current on existing practices in the data processing field, LIMS enhancements, various sample collection and laboratory procedures and environmental regulations
- Uses written communication to express ideas and programming needs to IT staff and other division personnel
- Support the definition and implementation of more efficient processes around LIMS/ELN change management
- Efficiently identifies and resolves project issues
- Effectively communicates project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed
- Advanced knowledge of LabWare LIMS and ELN including modules and interface capabilities
- Advanced knowledge of other PC and standard software to include spreadsheet, word processing and database programs
- Advanced knowledge in instrument interfaces for data entry into LIMS
- Advanced knowledge of LIMS systems in environmental laboratory settings
- Advanced skill in retrieving data from other databases and reviewing data
- Technical leadership experience
- Ability to work and communicate effectively with professional, laboratory, and IT staff
- LabWare LIMS Admin training
- LabWare ELN training
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Associate, Quality Control Resume Examples & Samples
- Perform assays in support of viral clearance, validation studies, routine testing, and investigations, including TCID50/mL and in vitro adventitious virus assays
- Support the timely completion of Process Biochemistry and viral clearance activities
- Review PVR protocols and reports, as well as raw data, in support of viral clearance studies
- Review and revise SOPs
- Participate in laboratory support functions, including but not limited to, virus and cell bank preparation and characterization, maintenance of indicator cell lines, equipment/instrument validation and maintenance, and testing of cell lines
- Support the validation of new analytical instruments and technology in QC Virology
- Minimum of 5 years experience in Virology laboratories in the Pharmaceutical industry,
- Critical skills include: good organizational skills, strong communication skills, and ability to work with multiple teams with appropriate attention to detail
- Knowledge of GMPs and global quality systems
- Knowledge of FDA/EMA regulations
- Experience in Trackwise, Oracle, and myCIMS would be helpful
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Senior Associate, Quality Control Resume Examples & Samples
- Lead or participate in Quality subteam in conjunction with PQM management as well as participate in asset team meetings to provide timely and effective communication of relevant program quality information, drive consensus and alignment around team proposals and decisions as well as coordinate quality timelines to meet Asset deliverables
- Performs Quality approval of key documentation such as method validation, stability and development protocols and reports as assigned by PQM management
- Champions improvement processes and supports self/team to meet established measurable targets/goals. Independently manages and executes projects aligned with department goals. Provides guidance on Asset strategies. Plans quality project(s) objectives, priorities, and timelines. Manages multiple tasks efficiently and resolves competing priorities
- Assists with the preparation of the Annual Product Review (APR) and excipient risk assessments with limited supervision from PQM management
- Authors sections of Regulatory submissions and agency responses as assigned. Performs QA approval of regulatory submissions and agency responses as assigned
- Addresses requests for Quality related documentation (is… CoA’s, Certification for absence of product/process impurities) to support submission and approval of regulatory filings and responses to agency queries for drug substance and drug product for all regulatory agencies, US, EU and ROW as assigned by PQM management with limited supervision
- Participates effectively in a leadership or membership role for site cross-functional teams as a representative of Product Quality Management
- Minimum of 4 years GMP and QA experience with at least 3 years Quality Systems Experience
- Experience managing mid to large projects in a cross-functional global environment
- Effective collaboration skills, seeks common ground and solves problems for the good of all
- Listens proactively
- In-depth knowledge of operations/quality systems/directives and apply the knowledge within the team/project management routinely
- Excellent technical writing, presentation and oral/written communication skills
- Lead projects and conduct complex problem solving through facilitation/escalation
- Mature leadership approach and understanding of their personal communication style and how to flex to others effectively
- Comfortable with high workload in short turn around, high level of ambiguity
- Assist in setting/reporting measurable goals and target and mitigation plans, as appropriate
- Possesses strong organizational skills with ability to multi-task and coordinate multiple activities in parallel
- Good knowledge of FDA/EMA regulations and compliance
- Formulate solutions/options for team and reach out externally to regulatory/global teams for alignment
- Conduct impact assessment related to compliance (e.g., global directives, audit finding/readiness, deviations)
- Leadership competencies include: Follow up, Decision Making, Communication, Collaboration and Innovation
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Master Associate, Quality Control Resume Examples & Samples
- Coordinate day-to-day operations within lab to ensure materials and products are sampled, aliquoted and distributed within the accepted time frames. Interprets data and resolves technical issues for group. Ensures lot release timelines will be met and coordinates testing performed at contract laboratories. Interfaces with regulatory and client auditors and ensures compliance with current regulations
- Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports. Ensure compliance with current regulations
- Personnel management and training
- Delegates and performs training of personnel to ensure they are properly trained and operating in a safe manner, and in compliance with GMPs
- Performs ongoing evaluation of staff performance, including yearly performance reviews
- Ensures that training and other personal development programs are in place for succession planning and the development of subordinates
- Ensures that performance opportunities are pro-actively managed through the Performance Management system
- Actively participate on cross functional teams (may include facilitation) and share information, as appropriate, with direct reports. Effectively communicate with supervisors, process engineers, and/or managers in other departments and sites
- Interface with other functions and departments
- Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management
- Assists manufacturing area managers or designees with areas identified for trouble-shooting, for corrective actions related to quality investigations
- Attends and actively contributes in regularly scheduled meetings with Quality Control staff and cross-functional groups
- Implement procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Provide accurate and timely delivery of data and reports to support regulatory filings
- Reviews raw material lot packages and releases RM lots for GMP manufacturing use. Creates and revises RM specifications and coordinates testing
- Leads and provides input into continuous improvement projects
- Drives the reduction of non-conforming events by performing corrective actions defined by the team
- Communicates deviations in product quality or discrepancies in paperwork to senior colleagues or manager, to ensure these are investigated
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Associate Quality Control Resume Examples & Samples
- Execute routine microbial methods and testing in a GMP biopharmaceutical environment, including but not limited to bioburden, microbial limits, endotoxin, growth promotion, PCR, microbial identification and biological indicator testing, for samples which include but are not limited to raw materials, environmental monitoring, GMP utilities, in-process and final drug substance, validation samples
- Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples, as well as supporting shipment of samples to Amgen network sites and contract labs
- Support routine activities over the weekends and public holidays as scheduled
- Troubleshoot problems and participate in investigations if required
- Participate in equipment installation, commissioning and qualification, reagent and sample qualification
- Participate method transfers, method verification/qualification/validation and contract lab qualification
- Participate in microbiology-related studies
- Revise documents and reports including but not limited to SOPs, JHA, technical reports
- 0-3 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry
- Knowledge and experience in GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods including aseptic laboratory techniques and monitoring of ISO Classified areas
- Experience with Quality Control testing and laboratory operations for common microbiological testing methods and equipment; particularly focused on bioburden, endotoxin, environmental monitoring, viable sample plates’ interpretation
- Responsibilities will include data analysis and communication of results, writing protocols and performing assay transfer/validation and equipment qualification/verification as well as maintaining and operating specialized equipment
- GMP laboratory operation including conducting sample management and data management, Part 11 compliance
- Interact effectively and ability to work well in teams
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Associate, Quality Control Resume Examples & Samples
- Review and/or participate in development and/or qualification studies to design methods for raw material rapid ID technologies that are suitable for a cGMP laboratory
- Search and review the literature to develop a strong understanding for raw material method validation approaches
- Author SOPs for new analytical methods and instruments
- Support the GMP instrument validation studies
- Design method validation experiments based on intended use per ICH guidelines
- Author protocols and reports for method validation and method transfers with defined acceptance criteria in accordance with ICH guidelines
- Develop appropriate statistical designs and perform statistical analysis of analytical method validation and transfer protocols
- Subject matter expert for new raw material technologies during regulatory agency inspections and agency engagements
- Collaborate with IT to develop LIMs interfaces for rapid ID technologies used for GMP release
- Author regulatory filings and responses
- Support QC’s global change control processes as a subject matter expert with respect to specification and method changes due to the implementation of new raw material methods and technologies
- Collaborate with venders to resolve technical issues and evaluate new technologies
- Lead and/or support method transfers from Analytical Development to QC, other Biogen sites and vender CLOs
- Lead and support troubleshooting and investigations related to new raw material methods and technologies
- Work closely with and train QC analysts
- Prepare project updates to share with senior leadership team and present at staff meetings
- Seek out new technology for raw material release testing and understand QC customer needs in order to develop business case for evaluating new technologies
- Technical expertise and strong understanding of raw material testing (such as Raman rapid ID, ICP-MS, HPLC/UPLC, particle size and quantitative appearance testing) and raw material release strategies for GMP manufacturing of biologics
- Experience working in a cGMP or regulated laboratory
- Proficiency in data management and reporting of analytical results in various data systems such as Lab Information Systems (LIMS)
- Work independently with minimal supervision to meet aggressive or accelerated timelines
- Background in spectral library validation and life cycle management is desired
- Knowledge of ICH guidelines on analytical method validation is desired
- Strong collaboration and organizational skills and an ability to work well in a team setting is required
36
Senior Associate Quality Control Resume Examples & Samples
- Communication skills (verbal and written) at all levels
- Bachelor’s degree in a Science related field is required
- 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with a minimum of 2 – 3 years of specific sample management/ stability programme management experience
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Senior Associate Quality Control Resume Examples & Samples
- Minimum of five years experience in regulated (bio)pharmaceutical QC environments, raw material QC experience is a plus
- Strong analytical skills with high knowledge of implementing analytical techniques into regulated GMP areas, proven technical leadership as a subject matter expert within the responsibilities
- Demonstrated problem solving skills, ability to multi-task operations, working autonomously and cross-functional
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness
- Fluent in German with a high level of English to be able to generate and review technical reports, SOPs and work stream papers
38
Senior Associate Quality Control Resume Examples & Samples
- Hold a third level qualification in science related discipline
- Have a minimum of 5 years in pharmaceutical/healthcare
- Possess key competencies to include planning/organization, problem solving, communication, teamwork, flexibility, coaching and motivating
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Associate, Quality Control Resume Examples & Samples
- * This position may require weekend and holiday support. ***
- Adherence to all, regulatory licenses and regulations,
- Coordinating inventory reconciliations with the impacted the QC department
- * The role supports manufacturing and QC operations 7 days a week. ***
- * This position will support regular weekend work and holiday support. ***
40
Senior Associate Quality Control Resume Examples & Samples
- To perform quality control (QC) of all types of cases as per standard procedure based on relevant experience with Individual Case Safety Report (ICSR) processing
- To ensure optimal training of employees in Global Safety (GS) concerning the QC process and generic case processing training
- To identify training needs in case handling departments in GS, GS GSC and online affiliates based on QC results
- Actively participate in all relevant QC meetings and ensure that QC results are analysed and QC reports are performed timely on a monthly basis
- Ensure proper feedback on all types of cases to our colleagues in India, DK and Argus Online affiliates
- Responsible for providing relevant QC documents to Management
- Support with training of new employees in Safety Operations, GS GSC and GS as well as re- training related to own responsibilities
- Support with training related to own responsibilities
- Actively participate in inspections and audits and take relevant actions
- Graduation and/or post-graduation in life sciences
- Preferably 3 years and above experience in PV
- Good knowledge of medicinal terminology and clinical pharmacology
- Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety
- A good knowledge of computers and databases. Fluency in English, written and spoken, is a must
- Strong ability to coordinate and prioritise tasks for ensuring department’s time and quality compliance concerning QC activities
- Good ability to guide and instruct other employees on quality procedures
- Ability to efficiently collaborate and communicate with stakeholders from the global NN organisation
- Continuous contact and interaction with relevant stakeholders with very diverse professional and/or cultural background
- Understand and respect GS stakeholders expectations and concerns
- Proactively contribute to solving GS customer’s needs
41
Associate, Quality Control Resume Examples & Samples
- Assists engineers in test of product/ system/ systems
- Conducts functional testing and analysis of newly developed products to ensure operation and reliability
- Learns new technologies and procedures to remain current with industry standards and new products
- Manages critical issues in a timely manner, participate in incident conference with related parties such as I/T / Operation / Test engineering during incident management
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Senior Associate Quality Control Resume Examples & Samples
- Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique. Experience with liquid-handling robots is also preferable
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
- Participate in the peer review of analytical data
- Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues
- Lead training of staff on technical aspects of job as required
- Develop, revise and implement procedures that comply with appropriate regulatory requirements
- Qualification of analytical equipment and related testing functions
- Participate in Analytical Method Transfers
- Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP
- Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
- Participate in regulatory agency inspections as required
- Plan and implement procedures and systems to maximise operating efficiency
- Manage and contribute to the achievements of department productivity and quality goals
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Associate, Quality Control Resume Examples & Samples
- Performing release and stability testing for finished products, including timely review of data and maintaining records following cGMP documentation practices
- Support for the execution of method validations, qualifications and transfers
- Participation in laboratory improvement projects, and troubleshooting of analytical methods in collaboration with teams as appropriate
- Maintenance of effective laboratory systems to ensure integrity of all laboratory results
- 0-2 years of relevant experience with analytical testing methodology (HPLC, GC, UV-Vis, Karl Fischer)
- Demonstrated technical abilities
- Solid presentation, oral and written communication skills; ability to communicate with peers and management
- Effective organizational skills; ability to multi-task and coordinate multiple activities in parallel
- Demonstrated instrument/method troubleshooting skills
- Knowledge of cGMP requirements and
- Familiar with FDA/EMEA regulations and compliance
44
Associate, Quality Control Resume Examples & Samples
- Support scheduling and day to day testing of raw materials
- Participates in a leadership or membership role for site cross-functional teams as a representative of the QC Raw Materials laboratory
- Ability to flex and respond to unexpected situations/demands; effectively problem solve and raise issues appropriately as well as provide resolution as necessary. Supports tracking of tasks and meeting Biogen deliverables. Training and mentoring more junior associates
- Demonstrated strong oral and written communication skills; ability to communicate with management and peers effectively
45
Biologics Associate, Quality Control Resume Examples & Samples
- The Quality Control Associate II/III coordinates the scheduling and performance of analytical methods to support the characterization, release, and stability testing of protein-based therapeutics in a GMP laboratory environment
- This position represents Biologics QC throughout the entire project lifecycle (i.e. initiation, implementation, sun setting), continuously interacts with the project sponsor and/or their representatives, and ensures that all procedures are performed precisely/accurately, and appropriately documented
- The position is also required to perform analytical methods such as SDS-PAGE, IEF, HPLC, ELISAs, and endotoxin
- Additional responsibilities include conceptualization, design, development and/or transfer of analytical methods from internal/external partners
- Administrative duties include generation/revision of laboratory quality systems and standard operating procedures, sample/stability program management, reference standard qualification, contract test laboratory oversight, and routine maintenance of the lab to ensure a continued state of regulatory compliance
- This position is expected to regularly contribute with the generation of relevant sections for regulatory submissions as an author or subject matter expert
- BS/MS in a biological science with 8+ years' (5+ years' w/ MS) experience in biologics, recombinant protein therapeutics, etc
- Working knowledge of GMPs, 21 CFR Part 11/210/211/600, ICH and USP guidelines
- Hands-on experience in the performance of protein-based analytical methods for characterization/release/stability (ELISA, HPLC, SDS-PAGE, IEF, cell-based bioassays)
- Demonstrated ability to operate in an aseptic environment
- Experience in the generation of standard operating procedures, test methods, stability reports, and other documents intended for use in a GxP environment or regulatory filings
- Excellent verbal and written communication skills with demonstrated ability to work both as an individual contributor and in a dynamic team environment
- Prior experience in a laboratory/project lead role
- Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines
- Familiarity with the administration and conduct of environmental monitoring programs (identification, sample frequency/location, periodic trending reports)
- Knowledge of biologics manufacturing and fill/finish processes
- Exposure to regulatory inspections, internal audits, and/or external vendor audits
- Familiarity with data analysis/statistical software packages (e.g. Empower, JMP, etc.)
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Senior Associate Quality Control Resume Examples & Samples
- Experience using a Tecan for Bioassay and Immunoassay testing
- Experience in Good Manufacturing Practices
- Ability to problem solve and troubleshoot lab testing technologies
47
Associate, Quality Control Resume Examples & Samples
- Release of Raw Materials for production use
- CoA generation in LabWare LIMS
- Exception review of OOS and deviations in TrackWise
- Change control assessment from Agile
- Reconciliation of inventory
- Document release in Oracle/OPM
- Must possess sufficient expertise to make decisions in ambiguous situations
- Understanding of basic scientific principles and quality systems utilized in QC as well as GMPs
- Demonstrated problem solving skills and instrument/method troubleshooting skills
- Participate effectively in a leadership or membership role for site cross-functional teams
- Provide input for complex problem solving while managing non-complex problems routinely
- Ability to effectively communicate with peers and management
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Associate, Quality Control Sample Management Resume Examples & Samples
- Perform receipt of QC samples, including processing and distribution to QC labs
- Manage QC retains and disposal of samples
- Revise and review SOPs
- Ship samples off site for testing
- Perform inventory of lab supplies and materials
- Perform supporting assays such as pH, cell counts, incubation of samples
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Senior Associate Quality Control Hplc / CE Resume Examples & Samples
- Report, evaluate, trend and approve analytical data
- Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope
- Execute protocols and perform assay transfer/validation and equipment qualification/verification
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
- May participate in lab investigations
- May provide technical guidance
- May train others
- May represent the department/organization on various teams
- May interact with outside resources
- Master’s degree OR
- Bachelor’s degree and 2 years of directly related experience OR
- Associate’s degree and 6 years of directly related experience OR
- High school diploma / GED and 8 years of directly related experience
- CGMP Experience
- Experience in Capillary electrophoresis
- Experience using Empower CDS, LIMS and/or SmartLab
- Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation
- Experience and knowledge of Data Integrity Requirements of QC Systems
- Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
- Excellent problem-solving capabilities and attention to detail
- Experience of collaboration within and across functional areas and outstanding customer service focus
