We are looking for a Senior Quality Assurance Specialist to support quality assurance activities in support of the manufacture, testing, and release of clinical product. The QA Specialist will review manufacturing batch records, deviations, change controls and disposition of clinical drug product. The Senior Quality Assurance Specialist is responsible for ensuring reviews of Manufacturing and Quality Assurance records are compliant with in-house specifications/standards and Good Manufacturing Practices. In addition, the Sr. QA Specialist will work to identify key continuous improvement opportunities to ensure phase appropriate quality systems are aligned with business strategy, industry standards and global regulatory expectations.
Reviews manufacturing and support records to confirm compliance with specifications and procedures
Assists Quality Assurance Management with product disposition activities.
Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
Works closely with Manufacturing and Analytical to resolve open issues resulting from record reviews and deviation issues
Work with all departments to ensure timely completion of manufacturing batch records, deviations, CAPAs, and change controls
Input batch/lot information into electronic databases
Review Manufacturing batch records and completes required documentation for batch disposition
Create, revise and review Quality System documents, including Standard Operating Procedures, protocols, and reports
Performs data audits, as needed
Provide training to site personnel and contractors on GMP and quality system procedures, as needed
Vendor oversight and management
Ability to prioritize daily activities in order to meet timelines in a fast-paced environment
Ability to monitor and report on assigned tasks, goals and objectives
Education and Experience Requirements
Bachelor's degree in Life Sciences, or related field and 5 to 8 years' experience in biopharmaceutical quality assurance
Excellent written and verbal communication skills
Experience with clinical product programs is required
Experience personalized medicine or cell therapy products is a bonus
We aim for a high-performing and collaborative culture that embraces diversity, equity and inclusion as a source of strength
Genocea Biosciences, Inc.