Quality Assurance Specialist, Supplier Quality

Quality Assurance Specialist, Supplier Quality

Position Summary

Moderna is seeking a Quality Assurance Specialist for a position based at their Cambridge, MA site. The individual in this role will be responsible for providing Quality Assurance (QA) support for Moderna‚ s Supplier Quality program. The individual will primarily work Supply Chain and vendors to ensure a robust supply of GMP materials are available to support Moderna‚ s clinical manufacturing programs. This individual will develop and implement supplier quality systems and governance, develop audit plans, audit vendors, and drive continuous GMP improvement in the supply chain. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

Responsibilities

  • Audit key Moderna material suppliers
  • Develop Audit Plans
  • Develop and implement supplier quality system improvements and governance
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
  • Develop and implement Quality Agreements
  • Lead risk assessments for critical materials
  • Support disposition of raw materials, drug substance, and drug product
  • Review stability protocols and reports
  • Collaborate with Supply Chain to drive improvements with key Moderna Vendors
  • Conduct, track progress, and trend results
  • Develop, track, communicate key metrics on supplier program
  • Review relevant sections of regulatory filings

Minimum Qualifications

  • Minimum education required: BS/MS in a scientific or engineering discipline
  • Minimum experience required: 5 years experience in the pharmaceutical/biotech industry, with a minimum of 2 years experience in Quality Assurance
  • Ability to travel 60%

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



Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Manager, Supplier Quality Assurance
Andover, MA Philips
Director, Supplier Quality Assurance
Andover, MA Philips
Quality Care Specialist
Woburn, MA Lahey Health
Quality Assurance and Regulatory Manager
Burlington, MA inVentiv Health
Director of Engineering - Quality Assurance
Andover, MA Raytheon
Manager, Quality Assurance
Marlborough, MA Sunovion