Sr. Specialist, Quality Assurance Auditor

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
July 12 2019
Ref
R1740
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr. Specialist, Quality Assurance Auditor

The Role:

Moderna is seeking a Senior Quality Assurance Auditor, reporting to the Associate Director of Quality Assurance, based at their Norwood, MA facility. This person will be responsible for auditing Moderna's suppliers and will be accountable for monitoring supplier performance; he/she will provide 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 GXP 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 GXP improvement in the supply chain. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. Additionally, the individual will create and maintain data tracking systems that govern the supplier quality program. The successful candidate must have experience in a biotech or pharmaceutical GXP environment.

Here's What You'll Do:
  • 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 supplier data
  • Track supplier conformance to audit commitments and corrective actions (SCAR's)
  • Review supplier change notifications and determine impact to internal systems
  • 10% Travel


Here's What You'll Bring to the Table:
  • BS in a scientific or engineering discipline with 5-8 years' experience in pharmaceutical / biotech industry within Quality Assurance, at least 2 years executing audits; MS preferred with 2-5 years' experience
  • 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.
  • Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures. Requires thorough knowledge of the department and company operations, policies and procedures.
  • High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-PL1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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