About the Company
We are currently looking to hire a Quality Control Manager for an integrated Contract Development and Manufacturing Organization. The company operates out of a state of the art cGMP facility designed to provide optimum efficiency, safety and regulatory compliance. This is an outstanding opportunity to have a management role within a company offering cutting-edge product development technologies and the high quality results for clients.
- Overseeing the operations of the QC lab group (10-15) to ensure accurate results, adherence to cGMP FDA regulations, company protocols, and timely completion of projects.
- Providing expert guidance to Manufacturing, Production, R&D, and other departments regarding quality and cGMP issues.
- Setting and reviewing performance goals for the QC lab group.
- Preparing and/or reviewing documentation required for regulatory submissions.
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- Bachelor Degree or above in Chemistry, Analytical Chemistry or related majo
- At least 10 years+ professional experience with management responsibilities within pharmaceutical Quality Control.
- At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment.
- Knowledge of cGMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
- Ability to troubleshoot analytical methods and laboratory instrumentation (e.g. HPLC, GC, Dissolution, wet chemistry).