Job Description

We're Hiring: Quality Control Analyst II, Sterility Assurance!
We are seeking to hire a Quality Control Analyst II, Sterility Assurance in Philadelphia.
Location: Philadelphia, PA
Work Mode: Work From Office
Role: Quality Control Analyst II, Sterility Assurance
Pay Scale: $100, 000 - $108, 000 (Dependent on Experience)
What You'll Do
∙Assist with the development of sterility assurance principles at the site in the areas of aseptic
processing, and contamination control.
∙Support the site compliance to the global microbial control standards/procedures on environmental
monitoring, critical utilities, contamination control strategy, clean-room management, microbiological
methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and
microbial risk assessments.
∙Assist with the design of the contamination control strategy.
∙Develop microbial contamination/Cross contamination risk assessments (HACCP/FMEA). Update the
assessments as needed based on the changes to the program.
∙Perform gap/risk assessments EM programs in response to regulatory updates (i.e., EU Annex 1)
∙Develop EMPQ strategy and provides oversight of the EM testing program for regulatory compliance.
What We're Looking For
∙4-5 years of experience in Pharmaceutical or Biotechnology.
∙Experience with Quality Control Sterility Assurance role or Microbiology.
∙Experience running or validating microbiology rapid safety methods (endotoxin, mycoplasma, and
sterility).
∙Good experience working in a cleanroom lab setting with biohazards / various chemicals.
∙SME on 2-3 of the Rapid Safety assays (Sterility via BacT, Endotoxin via EndoSafe, Mycoplasma via
BioFire and/or qPCR)
∙Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation,
identification, and enumeration techniques, etc.
Ready to ensure product safety? Apply now and join our quality team!

Job Tags

Work at office,

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