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.
- Oversees and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
- Provide Quality Systems support for complex technical projects and in troubleshooting activities.
- Assist with CDMO and product technical transfers to commercial state.
- Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
- Answers customer communications and helps build a customer support program.
- Reviews completed batch records for completeness, accuracy and compliance to process parameters.
- Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
- Supports SPL and participates in quality related training initiatives.
- Completes Deviations and CAPAs as needed.
- Serves as a back up for various responsibilities as needed.