Start Date: ASAP
Duration: 6 Months
Location: Northern MA
Description: The client is looking for QA Contractor who can come onsite and drive the project. They are expecting this person to have experience with room release, facility, and equipment qualification. The perfect candidate has experience within a clinical manufacturing environment.
Background:
• 7-10 years’ experience within biotech companies
Support Facility start-up in MTC-S (2nd floor and 1st floor) and MTC-N (GMP-P):
• Room qualification, room release, equipment and utilities qualification support
• Types of equipment: TFF, Skids, Fermenters
• SOPs updates, revisions and/or creation
• MBRs updates, revisions and/or creation
• VPMs updates, revisions and/or creation
• POL updates for phase appropriate raw material manufacturing
• SOP updates for phase appropriate raw material manufacturing
• MBRs for phase appropriate raw material manufacturing
• Cell Bank CTU Support
• CTU maintenance
• Process map for cell bank support
• Quality support of Cell Bank CTU for enable production or receiving of cell banks
