Manager Quality Control (3rd Shift)

Summary: Oversee the laboratory quality control team on 3rd shift including sample management and microbiology and chemistry testing of in-process, stability, and final drug products. This is a Monday-Friday, 3rd shift position.

Level will be determined based on experience.

Essential Duties and Responsibilities include, but are not limited to, the following:
•    Coordinates with members of Manufacturing, External Manufacturing, and Process Sciences to provide analytical support.
•    Supervises QC Analysts, distributes work load, and monitors progress.
•    Supervises sample management and testing.
•    Reviews test reports.
•    Ensures QC Analysts receive proper training.
•    Attends meetings to keep informed of manufacturing priorities.
•    Ensures that safety standards are maintained.
•    Ensures compliance with applicable cGMP regulations and SOPs.
•    Investigates Out of Specification and atypical test results as necessary.
•    Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
•    Responsible for all Safety and cGMP activities of associates working in Quality Control Third Shift including Chemistry, Sample Management, and Microbiology

Education and Experience:
•    Requires BS/BA in Life Sciences or related field with 7+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry, and 3+ years  supervisory/leadership experience.
•    Manager requires 7 years of relevant experience.
•    Sr. Manager requires 8 years of relevant experience.
•    Associate Director requires 10 years of relevant experience.