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 Supervisor of Document Control to join our growing Quality Assurance team.
The DC Supervisor is responsible for supervision of the site’s Document Control department, and develops and maintains cGMP-complaint Document Control systems. This position reports to the Manager of Quality Assurance.
- Oversees the functions of Document Control to include controlled procedure preparation & distribution, management of DCRs/Document Module in ZenQMS, creation/management of shipping requirements, issuance of shipping documentation and document archiving/indexing (including coordination with any third party document storage facilities).
- Responsible for continuous improvement of SPL cGMP Quality Systems to support Document Control in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.
- Compiles and communicates metrics associated with Document Control to management as required.
- Participates in audits, addresses audit findings and writes studies and investigations where necessary.