Scientific Protein Laboratories is a biopharmaceutical leader in the development and cGMP compliant manufacturing of heparin, pancreatin, heparin derivatives, naturally derived pharmaceuticals, and recombinant proteins from microbial fermentation. We have an immediate opening in Waunakee, WI (Madison area) for a QA Compliance Specialist to join our growing team.
This position is responsible for developing and overseeing execution of written procedures designed to ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production; record review and retention; and release of raw materials and product. The QA Compliance Specialist conducts deviation/discrepancy investigations, product investigations and completes CAPAs as necessary. The role also includes writing and reviewing SOPs, logbooks, and product protection plans. In addition, the QA Compliance Specialist performs internal audits as necessary, assists in writing Annual Product Review and assists in internal company training.
• Oversees and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
• Reviews completed batch records for completeness, accuracy and compliance to process parameters.
• Actively participates as quality support in the manufacturing departments.
• Supports SPL and participates in quality related training initiatives.
• Completes Deviations and CAPA's as needed.
• Serves as a back up for various responsibilities as needed