We are seeking a highly skilled and experienced professional for the position of Sterility Assurance Quality Control Manager. In this role, you will play a crucial part in ensuring the seamless implementation of contamination control policies across our dual manufacturing sites in Philadelphia. Collaboration with various stakeholders will be essential for the effective execution of these policies.
- Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
- Facilitate effective communication and coordination to harmonize sterility assurance efforts.
- Provide support for new product transfers, focusing on contamination control aspects of manufacturing processes and equipment design.
- Must have knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology and Annex 1 experience
- Oversee microbial method validations and rapid microbial methods associated with new products.
- Possess a deep understanding of QC sterility assurance principles and practices.
- Ensure compliance with industry standards and regulations related to sterility assurance.
- Bachelor's or advanced degree in a relevant scientific discipline.
- Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Extensive experience in leading QC sterility assurance programs within the Pharmaceutical or Biotechnology sector.
- Strong knowledge of contamination control policies, microbial method validations, and rapid microbial methods.
- Excellent leadership and communication skills.
- Familiarity with industry regulations and standards.
If you are a dynamic professional with a proven track record in QC sterility assurance and are ready to contribute to the success of our manufacturing operations, please apply for this exciting opportunity!