Co-op, Quality Assurance

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
September 20 2019
Ref
R1829
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role

Moderna is seeking a Quality Assurance Coordinator based at their Norwood, MA manufacturing site. This position is part of Moderna's Quality Assurance Systems and Compliance team responsible for ensuring quality oversight of our cGMP documentation and systems in support of cGMP Manufacturing and Testing activities. The main responsibility for this position is to provide quality oversight of systems, data, and processes including the eDMS (electronic Document Management System), eLMS (electronic Learning Management System), and eQMS (electronic Quality Management System). This position will assist in document control and record archiving activities, review and analysis of quality system data, and entry and organization of learning management data. The individual will work closely with various functional areas throughout the Norwood Manufacturing Facility such as Manufacturing, Quality Control, Digital, Manufacturing Science and Technology, Supply Chain, Pre-Clinical, and Facilities and Engineering teams.

Here's What You'll Do
  • Support day to day maintenance of the Veeva electronic Document Management System (eDMS)
  • Ensure documentation is Processed, Formatted, Issued, and made Effective accurately
  • Responsible for reviewing Document Change Controls to ensure proper revision control records and assisting in document periodic review processes
  • Maintains assigned document numbers, part numbers within their respective processes
  • Maintain inventory and organization of the QA document Archive Room
  • Scan and Upload documentation submitted for archival to electronic document management system (eDMS)
  • Develop and maintain a documentation database and assist in document issuance activities
  • Support other document control tasks as needed by QA Systems, Operations, and Supplier Quality
  • Support the day-to-day maintenance of the SAP SuccessFactors electronic Learning Management System (eLMS)
  • Review and upload new learning content as needed
  • Manage the training curricula for GMP Manufacturing, Preclinical Manufacturing, and various support staff
  • Create and maintain digital training folders for new hires
  • Work with QA document control to ensure new documents are appropriately integrated with the LMS for training
  • Review and analyze quality system data for trends
  • Perform other projects related to improvement of quality systems and procedures as needed and required by management
  • Perform tasks as needed to maintain cGMP compliance


Here's What You'll Bring to the Table
  • Minimum GPA of 3.4
  • Currently Enrolled Junior or Senior
  • Previous co-op or intern experience preferred.
  • Must be curious, eager, open to learning, and independent.
  • Must have excellent attention to detail
  • Ability to collaborate in a cross-functional, fast paced environment


Here's What We'll Bring to the Table
  • On-site subsidized cafeteria.
  • 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.


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-KP1

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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