Quality Control Analyst II, Sterility Assurance

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!