Sr. Quality Assurance Associate/Auditor

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
August 02 2017
Organization Type
Biotech
Sr. Quality Assurance Associate/Auditor

Position Summary

Moderna is seeking a Senior Quality Assurance Associate / Auditor for a position based at their Cambridge, MA site.  This position will transition to our new GMP Manufacturing site in Norwood, MA.  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 with Supply Chain and vendors to ensure a robust supply of GMP materials are available to support Moderna's clinical manufacturing programs. This individual will support supplier quality systems and governance, initiate audit plans, audit vendors, and drive continuous GMP improvement in the supply chain.  Additionally, the individual we create and maintain data tracking systems that govern the supply quality program.  The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.  Reporting to the Associate Director of Quality Assurance, this person will be responsible for auditing Moderna's suppliers and will be accountable for monitoring supplier performance.

Responsibilities

  • Execute supplier audits
  • Partner with supplier to establish relationships
  • Aide in the establishment and maintenance of policies and procedures for the supplier management program
  • Develop Audit Plans
  • Monitor supplier metrics to ensure supplier performance is measurable
  • Maintain key supplier data
  • Track supplier conformance to audit commitments and corrective actions (SCAR's)
  • Review supplier change notifications and determine impact to internal systems
  • 30% Travel

Qualifications

  • BS / MS in a scientific or engineering discipline
  • 3 years' experience in pharmaceutical / biotech industry within Quality Assurance executing audits
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

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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.