Associate II, Quality Assurance

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
April 26 2019
Ref
R1598
Discipline
Life Sciences, Biology
Organization Type
Biotech
Associate II, Quality Assurance

The Role:

Moderna is seeking a Quality Assurance Associate II for support and oversight of internal drug product manufacturing at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for rapidly releasing cGMP mRNA-based personalized cancer vaccines for evaluation in human clinical trials as well as all other mRNA drug products produced internally at Moderna. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products and/or depth of knowledge in drug product filling. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.

Here's What You'll Do:
  • Participate in quality focused teams across Moderna's broad ecosystem of functions.
  • Authors and reviews SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
  • Oversee and review executed electronic and paper batch record documentation.
  • Develop batch records, SOPs and training materials for startup of the Norwood Facility
  • Oversees execution of CAPAs, deviations and change controls in support of the drug product manufacturing.
  • Closely partner with peers for rapid disposition of personalized cancer vaccines
  • Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
  • Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
  • Monitor process operations to ensure compliance with specifications.
  • Assist in the investigation of procedural deviations.
  • Practice safe work habits and adhere to Moderna's safety procedures and guidelines.
  • Utilize knowledge to improve operational efficiency.
  • Participate in quality oversite of manufacturing through real-time observations of activities


Here's What You'll Bring to the Table:
  • 0-2 years of experience in a GMP manufacturing environment with a Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field, Associates with 4+ years related experience or 5+ years of related GMP experience
  • Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
  • Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
  • Exceptional written, oral communication, and organizational skills required
  • Experience with tech transfer desired.


Here's What We'll Bring to the Table:
  • Daily on-site subsidized cafeteria
  • 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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