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 two immediate Documentation Specialist openings in Waunakee, WI (Madison area) for a Documentation Specialist to join our growing Specialty Products and R&D teams.
The Documentation Specialist develops and maintains SPL documentation pertaining to the Specialty Products business and the R&D department’s operations. This position is responsible for generating, reviewing, and revising documents, including Standard Operating Procedures (SOPs), Manufacturing Instructions (MI's), validation protocols, Work Instructions, Design Qualifications, etc. The Specialist is also responsible for supporting manufacturing operations with deviations, non-conformances, change controls and investigations.
• Develop and maintain GMP documents and document control systems in support of the Specialty Products business and R&D operations including SOPs, MI's, Work Instructions, Design Qualifications, and validation protocols. Ensure that review and revision of all controlled documentation is conducted in a timely manner and in accordance with SPL SOPs.
• Support manufacturing operations with preparing and tracking deviations, non-conformances, change controls and investigations.
• Coordinate and assist in maintaining the cGMP training records for department staff in accordance with cGMP requirements.
• Monitor and help to maintain department compliance with cGMPs.
• Work directly with Quality Control, Quality Assurance, Validation, and Production in support of cGMP manufacturing operations and maintaining department cGMP compliance.
• Write clear and concise reports in support of Specialty Products Business and R&D operations.
• Assist in manufacturing operations and perform other duties as required.