Auto req ID: 2150BR
Job Posting Title: QC Stability Coordinator
Person Type: Regular
Job Summary and Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary: Performs a variety of activities to administer the stability program and manage data generated in support of the company’s quality program.
Essential Duties and Responsibilities include, but are not limited to, the following:
Coordinates with other departments to identify material to be put on stability.
Authors stability protocols and obtains necessary approvals prior to study initiation.
Performs review of analytical data and compiles into a central database.
Provides stability data necessary for the submission of various regulatory documents.
Provides stability data to other departments upon request.
Orders stability chambers and related equipment, as needed.
Maintains stability chamber inventory and monitors chamber performance.
Removes samples from chambers according to protocol pull schedules and submits to appropriate testing group.
Prepares samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber).
Interacts with outside customers or functional peer groups.
May be responsible for maintaining a specific project.
Complies with all pertinent regulatory agency requirements.
Participates in required training activities.
BioSpace.com - 30+ days ago