Our Danvers, MA client is a pharmaceutical company with great company atmosphere, benefits, and
longevity. We are seeking a QC Manager with extensive experience with small molecule
* The successful candidate will manage all internal and outsourced laboratory operations.
* Establish SOPs for all aspects of lab operations and supervise and train staff.
* Provide the primary technical support for the QC laboratory and must ensure that all testing
and investigation resolutions are performed in a high quality and timely manner.
* Responsible for managing stability programs, and for generating a C of A for the release of
drug substance, and finished drug products by QA.
* The ideal candidate must have extensive laboratory testing experience including, but not
limited to HPLC, KF--.
* Responsible for quality control testing of in-process, finished product and stability
Other responsibilities include in part:
- Oversight of laboratory testing, including investigations, deviations, and troubleshooting
in a technical and a managerial role.
- Coordinate chemists to ensure that all testing and calibrations are completed according to
schedule and meet all cGMP requirements.
- Responsible for monitoring instrument qualifications and ensuring that qualifications are of
analytical instruments are up to date and meet regulatory requirements.
- Develop test protocols, review and write technical reports, write SOPs, and review stability
data. Work closely with QA toimplement orocedures in compliance with regulatory requirements.
- Experience with small molecule background. Karl Fisher moisture, assay, and impurities.
BS, MS degree in chemistry with 8 plus years experience in pharmaceutical operations,
including 3 years of QC supervisory experience in a cGMP environment.
Excellent verbal and written communication skills and takes the initiative to work
collaboratively across multiple functional areas.
Knowledge of FDA regulations, ICH guidelines, CFR, USP/NF, and validation guidelines.
Extensive knowledge and experience in QC, including analytical chemistry, and stability.
Previous supervisory experience is required.
Previous experience in testing and releasing a finished pharmaceutical product for commercial
use is required