Senior Analyst 1, QC Microbiology
Technology
Job Description
The Senior Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Senior Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.
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What You’ll Do
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- Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test.
- Leads sample collection and manages sample logistics for testing.
- Supports testing for all qualification and study directed testing.
- Supports investigation of routine OOS assays and events.
- Conducts qualification and validation protocols.
- Leads sterility testing.
- Reviews intermediate lab testing results.
- Troubleshoots complex assays.
- Writes and assists with document preparation and review.
- Manages project timelines.
- Assists management with training and onboarding of new staff as needed.
- Embraces LEAN lab and six sigma principles and applies them to laboratory processes.
- Champions projects and project management as assigned.
- Performs other duties, as assigned.
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Knowledge, Skills, and Abilities
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- Excellent attention to detail. Seeks opportunities for improvement and suggests ideas for improvement projects.
- Advanced technical writing and problem-solving skills.
- Excellent verbal and written communication skills. Ability to review and interpret data Ability to present information to the team.
- Able to develop and assign tasks according to a structured plan. Ability to overcome and respond to challenges.
- Able to complete tasks independently and with occasional guidance from Supervision as needed. Ability to implement structured plans.
- Drives performance, identifies areas of improvement.
- Ability to support audits and client interactions.
- Self-driven, dedicated, and systematic and can plan your day and develop plans for others in a structured way.
- Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself and others.
- Ability to work cross-functionally with a diverse team and represent the team.
- Self-motivated and collaborates with analysts.
- Champions a collaborative attitude for the team.
- Must be flexible to support 24/7 manufacturing facility.
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Minimum Qualifications
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- Bachelor’s with 2+ years of relevant Microbiology experience; OR,
- Master’s with 0 years of experience.
- Experience with aseptic production & support.
- 1-3 years in a GMP environment.
- Advanced understanding of GMP, GLP, GDP requirements.
- Advanced knowledge in Microbiology theory.
- Advanced knowledge of Microbiology testing and laboratory experience.
- LIMS experience.
- Experience with document control including reviewing and editing technical documents.
- LEAN lab and six sigma six training and/or certification
- Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
- Intermediate LIMS software training.
- Knowledge or training of FDA regulations (cGMP, cGLP, cGDP).
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Preferred Qualifications
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- Master’s with 1+ years of experience.
- 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage.
- Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing).
- Advanced experience with microbial ID systems, ability to trouble-shoot complex equipment and instrumentation (MALDI, MicroSeq).
- Advanced LIMS / Trackwise software training.
- Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities
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