Senior Associate, Quality Assurance

Position Summary The Senior Associate, QA will provide Quality Assurance (QA) oversight for the production of drug products across end-to-end operations (technology transfer through clinical production and commercialization). Provide QA oversight of Quality Control (QC) activities to ensure compliance with applicable regulatory requirements (e.g., GMP, GLP) and internal quality standards, supporting product quality, safety, and data integrity. Provide quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle. Principal Duties and Responsibilities Provide QA support for site operations, including in-house manufacturing and CDMO activities, and supply chain distribution. Provide on-floor support during critical manufacturing processes. Support releasing manufacturing suites and batch/product changeovers. Participate in cross-functional teams to resolve quality issues impacting operations. Review/approve key documentation (MBRs, product specifications, change controls, deviations, CAPAs). Participate in Change Control Review Board and provide quality input. Perform quality system activities (Change Control, Deviation Reporting, CAPA). Author/review/approve internal quality documents (SOPs, investigations, etc.). Support QA leadership for compliance and inspection readiness. Support Annual Product Review (APR) reporting and process control analysis. Review/approve QC documentation (test records, analytical data, logbooks). Ensure adherence to SOPs, test methods, and regulations (FDA, EMA, ICH). Review/approve Certificates of Analysis (CoA), analytical results/reports, and stability data. Qualifications Bachelor’s degree in a relevant scientific discipline. 5+ years’ experience in pharmaceutical, biotech, or medical device. Strong knowledge of GMP and GLP and regulatory expectations. Understanding of analytical testing and laboratory workflows. Familiarity with OOS investigations, deviations, and CAPA. Excellent organizational skills and attention to detail. Good verbal and written communication; strong teamwork skills. Computer literacy (MS Office, Excel, PowerPoint). Ability to make decisions and resolve issues with minimal guidance. Working Conditions Office environment (primary); clean room/manufacturing environment when required. Salary Range $109,000 USD - $121,000 USD #J-18808-Ljbffr Scorpion Therapeutics