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. This position works closely with laboratory staff, Quality Control Management, Regulatory Affairs and Quality Assurance.
The Senior Director of Quality Control is responsible for managing QC and validation functions across all product lines. Oversees Microbiology, Raw Materials, Stabillity and Analytical labs. Also responsible for ensuring successful and timely completion of deliverables addressed during project execution. Requires considerable judgment and skills to identify and rectify test method problems and make recommendations for corrective action necessary to assure conformity with Quality specifications. This position works closely Operations, Quality Assurance and Regulatory Affairs to develop and maintain a comprehensive program that assures consistent quality throughout the production platform.
This is a temporary, part-time position where the primary function is the daily care and maintenance of the LFB USA rabbit colony used to produce pharmaceutical products. Tasks must be carried out in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and must be accurately documented to maintain compliance with FDA mandated Good Manufacturing Practices (GMPs) and USDA AWA regulations.