Moderna Therapeutics, Inc

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Co-op, Quality Assurance

at Moderna Therapeutics, Inc

Posted: 9/20/2019
Job Status: Full Time
Job Reference #: R1829-1
Keywords: database

Job Description

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.


Our Mission and Vision

At moderna, we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA Therapeutics™ by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna therapeutics does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to moderna therapeutics from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and moderna therapeutics and do not obligate moderna therapeutics to pay fees if we hire from those resumes.

EEO Disclosure

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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Posted 28 Days Ago

Full time

R1829