Manager Quality Control (3rd Shift)

Rensselaer, New York, United States of America
Jul 21, 2021
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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.