Sr. Specialist, Quality Assurance Auditor

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
March 26 2019
Ref
R1538
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr. Specialist, Quality Assurance Auditor

The Role:

Moderna is seeking a Senior Quality Assurance Auditor for a position based at their Norwood, MA facility. 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. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. Additionally, the individual we create and maintain data tracking systems that govern the supplier 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.

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
  • 5-8 + years' experience in pharmaceutical / biotech industry within Quality Assurance 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.


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches [ Cambridge ] On-site subsidized cafeteria [ Norwood ]
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays


Why join Moderna Therapeutics

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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