Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of cGMP-compliant products including pancreatic enzymes and heparin. Lately, SPL has embarked in a new direction of expanding and diversifying its product portfolio and pipeline by actively investing in new technologies and products including both external partnerships and internal development efforts. We have an immediate opening in Waunakee, WI (Madison area) for a Quality Assurance R&D Compliance Specialist to join our growing Quality Assurance team.
The QA R&D Compliance Specialist assists in developing, implementing and maintaining a specialized Quality System to support the R&D programs including quality assurance for GMP and GLP supplies. This position is responsible for assisting in the technical transfer of products to SPL. The incumbent must ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention. In addition, the QA R&D Compliance Specialist conducts deviation/discrepancy investigations, product investigations and completes CAPAs as necessary. The Specialist will also write and review SOPs, logbooks, and product protection plans and assist with customer inquiries. When necessary, the QA R&D Compliance Specialist performs internal audits and backs up the Sr Manager of QA.
SPL offers competitive pay, a comprehensive benefits package and a pleasant work environment.