(Contract) Specialist, Quality Assurance

Norwood, MA
August 24 2019
Life Sciences, Biology
Organization Type
The Role:

Reporting to the Sr. Manager, the QA Specialist will be responsible for providing quality oversight for the cGMP manufacturing of personalized cancer vaccines at the Norwood, MA site. The main responsibility for this position is to provide quality oversight of the manufacturing process for drug substance and drug product formulation. This assignment is based at our Norwood, MA location, and is expected to last 6 months.

Here's What You'll Do:
  • Identify, classify and report deviations, as appropriate and typically works on more complex minor and/or major deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next mile stone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensure timely closure of investigation.
  • Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
  • Author and review SOPs, test methods, protocols and reports. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
  • Review pre-executed batch records and independent technical review of documentation post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable.
  • Participate in quality oversight of manufacturing, real-time observations of activities
  • Collaborate with Manufacturing to resolve equipment and process issues
  • Conduct internal audits, track progress, and trend results
  • Work closely with others to recognize opportunities for improvement and drive change using Quality systems
  • Participate in internal audits for compliance with SOPs, GMPs, and regulations

Here's What You'll Bring to the Table:
  • A Bachelor's degree in microbiology, biology, or chemistry.
  • 3-5 years of quality assurance experience in pharmaceutical industry providing oversight to manufacturing operations.
  • Demonstrated knowledge of cGMPs in a manufacturing environment.
  • Strong independent judgement and decision-making abilities.
  • Demonstrated problem detection and problem resolution skills.
  • Must possess demonstrated organizational skills.
  • Must possess excellent verbal and written skills.
  • Ability to effectively collaborate effectively in a fast-paced, dynamic, cross-functional matrix environment

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.

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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