Stability Co-ordinator 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:
- 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.
Education and Experience:
