Quality Control Microbiologist
2 weeks ago
At INCOG BioPharma Services, we are seeking a highly skilled Quality Control Microbiologist to join our team. As a Quality Control Microbiologist, you will play a critical role in ensuring the quality and safety of our parenteral injectable products.
Key Responsibilities:- Develop and implement a world-class Quality Control platform, including a robust environmental monitoring program and laboratory processes that adhere to procedures and regulatory requirements.
- Partner with leadership to develop PM and calibration plans to coordinate upkeep, conformity, and IQ/PQ/OQ of instruments and laboratory environment.
- Collaborate with the Quality Team to build a laboratory safety program that ensures a safe and quality-minded environment for all personnel working in the laboratory.
- Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
- Maintain a constant state of safety and inspection-readiness in the QC laboratories, using knowledge of quality principles, cGLPs, cGMPs, and regulatory standards.
- Support laboratory investigations using troubleshooting tools to identify errors and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
- 2+ years of microbiology, biology, or other related experience.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
- Experience with using laboratory instrumentation that analyzes sterility, endotoxin, and bioburden.
- Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, minitab, etc.).
- B.S. in Biochemistry, Biology, or Microbiology.
- Paid time off, based on tenure.
- 11 paid holidays.
- 401(k) plan with company match up, vested immediately.
- Choice of health & wellness plans.
- FSA and HSA options.
- Onsite wellness facility.
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations.
We are an equal opportunities employer and welcome applications from all qualified candidates.
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