Responsibilities of the QC Manager:
- Provide oversight and support of internal and outsourced cGMP stability programs.
- Collaborate with and gather data at external CMOs/CROs.
- Oversight of routine stability testing and trending in accordance with regulatory guidelines.
- Serve as point person for organization of all internal and external Quality Control commercial stability data.
- Contribute to Deviations, Out of Trend (OOT) or Out of Specification (OOS) investigations.
- Provide technical expertise and troubleshooting to support internal and external analytical quality control.
- Author and review technical documentation (e.g. SOPs, protocols, reports).
Requirements of the QC Manager:
- BS / MS in a relevant field with 5+ years of experience working in a QC industry (cGMP).
- Experience utilizing Quality management systems.
- Excellent communication and public speaking skills.
- Knowledge of analytical chemistry such as chromatography and method transfer/validation.
- Any experience with regulatory affairs is a plus.
- Paid time off
- Medical and dental insurance
- 401K Match
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.