Senior Compliance Specialist - Quality Assurance

Compiles and reviews production history records for Finished Products. Ensures all documentation and data are present and complete. Coordinate product release with QA Supervisors, attend Product Release meetings and weekly production meetings for problem solving, scheduling and inventory purposes.
The candidate will be responsible for ensuring that product quality issues are identified as early as possible, and remedied through the corrective and preventive action system.
Perform tracking and trending activities on final product release on a monthly/quarterly basis.
Coordinate Finished Product review against Regulatory filings and CMC controls.
Ensure that the CAPA handling process of products is monitored, reported, and improved through involvement with site management, product changes, management review, and corrective and preventive action activity.


Education/Experience Requirements: Bachelor?s Degree (B.S./B.A.) in a scientific discipline, along with 5-6 years industry experience in a compliance or regulatory related function (in the pharmaceutical or medical device industry).Knowledge of regulations and standards affecting Pharmaceuticals and Biologics and prior experience in GMP/GLP standards and guidance documents are desired. Strong technical background in regulated products, whether through Quality or Technical Product knowledge.Good project management skills are required and a working knowledge of statistical techniques. Incumbent needs to possess good presentation skills, excellent written and verbal skills.