QA Specialist II - Operations
A global leading CDMO is looking to bring on a QA Specialist to join their site in Boston, MA. They recently doubled their lyophilization and manufacturing capacity, acquired a brand-new campus, and is exploding in both manufacturing and personnel capacity. They are looking for an individual who is enthusiastic about learning and wants to grow with the company. With how quickly they are expanding, it is an ideal position to show off your leadership skills with a company that values each individual member of their team.
- Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
- Review and approve master batch records for the timely initiation of GxP manufacturing activities
- Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
- Perform risk assessments to comply with internal procedures and external guidelines
- Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
- minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
If this sounds like a good fit, please don't wait to apply!