The Analyst, Quality Control (QC) Sterility Assurance role will support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.
- Assist with the development of sterility assurance principals 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.
- Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
- Assists with the troubleshooting contamination related issues occurring in internal and external manufacturing sites.
- Assists QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
- Support EM programs
- Bachelor's degree in a relevant discipline (biological sciences or equivalent).
- Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP and JP monographs for microbiology.
- Knowledge of microbiological and sterility testing, media fills, environmental monitoring, microbiology methods (endotoxin, mycoplasma, and sterility).
- Experience with microbiological risk assessments.