Manager Quality Control (3rd Shift)

Location
Rensselaer, New York, United States of America
Posted
Jul 21, 2021
Ref
22836BR
Discipline
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.