QA Documentation Coordinator

About the Role The role provides support for site-wide Quality Assurance Programs including GMP Documentation and Change Control to meet Canadian and FDA GMP requirements. It oversees processing of GMP Documents, revisions, posting, archival and storage at the SPCI QA Documentation Center and Third-party Documentation Storage Facility. The role also serves as a backup for Specialist, QA (Documentation) as needed. What You'll Do

• Organize and coordinate archival, retention and retrieval of GMP Documentation generated at SPCI.
• Support Regulatory Inspections and Customer Audits through timely retrieval of Documentation.
• Support revision and posting (making effective) of Quality Control Documents (e.g., Test Methods, Specifications) and Master Production Documents as per assigned Change Control tasks in a timely manner.