Quality Control Microbiologist

2 weeks ago


Reston, Virginia, United States INCOG BioPharma Services Full time
Quality Control Microbiologist Job Description

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.
Requirements:
  • 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.
Why INCOG BioPharma Services?
  • 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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