What are the responsibilities and job description for the QC Sterility Assurance II position at R&D Partners?
Duties:
- 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
Qualifications:
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- Minimum four to Five (4-5) years of experience in the pharmaceutical industry within a Quality Control Sterility Assurance role or Microbiology role\
- Experience running or validating microbiology rapid safety methods (endotoxin, mycoplasma, and sterility).
- SME on 2-3 of the Rapid Safety assays (Sterility via BacT, Endotoxin via EndoSafe, Mycoplasma via BioFire and/or qPCR)
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.
Salary : $100,000 - $110,000
