QA Specialist II - Validation
- Greater Boston area
A leading CMO is seeking an experienced QA Specialist II to join their growing team. This role will work with several different clients who specialize on numerous treatment areas. If you're looking for a dynamic work environment and take on your next challenge, this is the role for you!
The QA Specialist II will provide support to the Validation teams across multiple locations and will be responsible for the approval of GMP engineering and validation documentation. This role will support quality system compliance while providing input to documentation.
- Review and approve validation protocols and reports
- Provide oversight for GMP validation activities such as deviations, CAPAs, and change controls
- Participate in continuous improvement of Quality Systems, making sure everything is adhering to cGMPs and quality regulations
- Support manufacturing operations with the review of batch records and documentation
- 10+ years of related pharmaceutical industry experience within a Validation or Quality Assurance focus
- BS in a Science or Engineering discipline
- Working knowledge of Quality Systems and cGMP requirements
- Knowledge of validation methodology, software development life cycle, and Part 11 compliance
- Strong communication and organizational skills