What are the responsibilities and job description for the Temp-Compliance Specialist-OSD position at Alkermes?
Summary
The Manufacturing Compliance Specialist establishes, monitors, and maintains GMP systems for the OSD manufacturing processes.
Essential Functions
- Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
- Work with the Solid Oral Dose team to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production).
- Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
- Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development.
- Assure the resolution of deviation corrective actions, action items from Change Control systems, and any audit non-compliance items.
Required Education and Experience
Physical Requirements
Must be able to work in an office and a manufacturing environment.
