Sterility Assurance Specialist II

R&D Partners is seeking to hire a Quality Control Analyst II, Sterility Assurance in Philadelphia.

Your main responsibilities as a QC Analyst II:

• 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 are looking for in a QC Analyst II:

• 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.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$100,000 - $108,000 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.