Andover, United States
3 months ago
The individual will provide Quality Assurance oversight in support of a site product enabling engineering project. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various validation testing documents, deviations, and change controls. The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing and Quality Control (QC) instruments and therefore validation and quality assurance experience in a manufacturing and / or Quality Control laboratory GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing.
• Bachelor’s Degree in engineering or life sciences
• 5 years of validation/QA experience in a GMP environment
• Experience with change control as a Quality Assurance approver
• 1 year of experience with Trackwise change control software (or similar)