The Stability Coordinator/Writer is responsible for managing the Stability Program executed in the Quality Control laboratory. Individual will integrate various sources of information into a uniform style and language for regulatory compliance and may coordinate the review, approval, and revision of SOPs, specifications and forms as needed. Works with initiators to rewrite, clarify, or reconstruct controlled documents. Also handles sample management; logging, tracking, shipping, etc. This position works closely with laboratory staff, Quality Control Management, Regulatory Affairs and Quality Assurance.
- Coordinates stability testing including materials, equipment, analyst availability, sample log-in, sample shipping.
- Generates Stability Protocols, Stability Updates, and Stability Reports. Ensures that studies are initiated and executed according to FDA and EU guidelines.
- Assists with data review, data tracking with QC Sample Database and associated tracking systems such as Master Testing Update, product specific summary files and study specific trending files.
- Assists with coordination and management of control/standard qualification program.
- Assists with set up and maintenance of analyst training program.
- Authors or assists in generating written documents, such as Reference Standard reports, Annual Product Review, OOS Summaries, Validation Protocols/Reports and other documents that support the operation of the Quality Control laboratory.
- Assists with the collation and review of data packages for the release of composite, intermediate, drug substance, and drug product.
- Assists with the collation and review of data packages and the generation of Data Summaries (as needed for Study data).
- Assists with the preparation and submission of original data packages to Quality Assurance.
- Attends intra/interdepartmental meetings to assist in the development/improvement of stability testing procedures.
- BS degree (preferred) in a scientific discipline. 2+ years’ experience in a QC/GMP environment.
- Excellent organizational skills with the ability to communicate well and exhibit a high level of professionalism.
- Strong computer skills and experience in technical writing in QA/QC.
- A high level of initiative, good judgment, and interest in being a facilitator for people and projects.
- Ability to work both independently and on teams.