Sr. Quality Assurance Specialist/Manager, External Quality

Sr. Quality Assurance Specialist/Manager, External Quality

Position Summary

Moderna is seeking a Sr. Quality Assurance Specialist/Manager for a position based at their Cambridge, MA site. The individual in this role will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development at Moderna‚ s contract manufacturing facilities. The individual will primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

Responsibilities

  • 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 and approve validation protocols and reports to ensure compliance
  • Review protocols, 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
  • Lead/participate in supplier audits
  • Review relevant sections of regulatory filings

Minimum Qualifications

  • Minimum education required: BS/MS in a scientific or engineering discipline
  • Minimum experience required: Six years experience in the pharmaceutical/biotech industry, with a minimum of three years experience in Quality Assurance
  • Ability to travel 30%

Preferred Qualifications

  • Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products
  • 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

Competencies

  • Effective Communication
  • Flexibility/Adaptability to Change
  • Accountability
  • Independence/Teamwork
  • Decision Making
  • Contributing to Team Success
  • Information Monitoring
  • Technical/Professional Knowledge


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