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.