Sr. QA Specialist, External QA
Moderna is seeking a Quality Assurance Specialist reporting to the Senior Director External Quality Assurance. The individual in this role will be responsible for providing Quality Assurance (QA) support for Moderna's External Quality Assurance. The individual will primarily work with Supply Chain, Manufacturing and vendors to ensure a robust supply of GMP materials are available to support Moderna's clinical manufacturing programs. This individual will execute the quality systems for raw material qualification, audit vendors, provide operational quality support for external manufacturing and testing, and drive continuous GMP improvement in the supply chain. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.
- Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
- Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
- Review protocols and approve validation protocols and reports, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
- Support disposition of raw materials, drug substance, and drug product
- Review stability protocols and reports
- Collaborate with Manufacturing to resolve equipment and process issues
- Conduct audits, track progress, and trend results
- Collaborate with Supply Chain to drive improvements with key Moderna Vendors
- Execute the supplier change notification and corrective action programs
- Performs compliance monitoring of area operations, including trending of SCARS and evaluating effectiveness of corrective actions.
- Performs monthly review of release cycle times and SCAR cycle times for trending.
- Attends supplier audits and quarterly business reviews as needed.
- Participates in regulatory and customer audits.
- BS in a scientific or engineering discipline
- 5 years experience in the pharmaceutical/biotech industry, with a minimum of 2 years experience in Quality Assurance
- Ability to travel 60 %
- Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products
- Knowledge of raw material qualification programs
- Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
- Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
- Solid understanding of CMC requirements for INDs, BLAs, and other regulatory filings
- Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.
- Experience in participating in deviation investigations, determining root cause, and developing corrective action plans
- Ability to identify technical problems and suggest resolution of the issues
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.