Temp-Compliance Specialist-Manufacturing

Summary

The Manufacturing Compliance Specialist establishes, monitors, and maintains GMP systems for the Filling manufacturing processes.

Essential Functions

• Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
• Work with the Filling 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

• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum three years experience in Quality Assurance or manufacturing in the pharmaceutical or medical device industry
• Experience executing and reviewing Good Documentation Practices.

Physical Requirements

Must be able to work in an office and a manufacturing environment.