Scientific Protein Laboratories LLC (SPL) is a biopharmaceutical world leader in the development and cGMP compliant manufacturing of pancreatic enzymes and heparin. We have an immediate opening in Waunakee, WI (Madison Area) for a Quality Assurance Compliance Specialist.
This position is responsible for the execution of written procedures designed to ensure current Good Manufacturing Practice (cGMP) compliance in such areas as record review and retention; raw materials; environmentals and other specified utility systems. The QA Compliance Specialist reviews manufacturing batch records, conducts deviation/discrepancy investigations, and completes CAPAs as necessary. They will also write and review SOPs, logbooks, and product protection plans. The QA Compliance Specialist is responsible for performing internal audits and assisting the Annual Product Review.
• Materials Management: Oversees and executes raw material related activities, coordinates and manages retest procedures, maintains supplier qualification programs, oversight of inventory control (Materials on hold, expired materials, new materials etc.)
• Reviews completed batch records for completeness, accuracy and compliance to process parameters.
• Actively participates as quality support in the manufacturing departments.
• Completes Deviations and CAPA's as needed.
• Serves as a back up for various responsibilities as needed.
• Four-year degree in Chemistry or closely related discipline
• Two or more years of applicable work experience
• Pharmaceutical manufacturing experience preferred
SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.