Specialist, Quality Assurance

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
August 24 2019
Ref
R1716
Discipline
Life Sciences, Biology
Organization Type
Biotech
Specialist, Quality Assurance

The Role:

This role is an exciting opportunity to be a critical part of the Personalized Cancer Vaccine (PCV) QA team. The main responsibility for this position is to provide quality oversight for PCV manufacturing. This individual will work closely with Manufacturing, Materials Management, Quality Control, Digital, and the Manufacturing Science and Technology teams supporting the ongoing Phase 1 study and support the successful launch of Phase 2.

Success in this position requires knowledge in all aspects of cGMP manufacturing, the ability to work hands on to support on-the-floor operations, an energetic personality with the ability to collaborate in a cross-functional, very fast paced and fluid environment. This position will support Operations for a Tuesday through Saturday or a Sunday through Thursday shift.

Here's What You'll Do:
  • Identifies, classifies and reports 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.
  • Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
  • 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.
  • 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
  • Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
  • Participate in internal audits for compliance with SOPs, GMPs, and regulations.
  • Other activities as deemed necessary.


Here's What You'll Bring to the Table:
  • Bachelor's degree in biology, or chemistry, microbiology, or equivalent.
  • A minimum of 2 to 5 years of Quality Assurance experience in the pharmaceutical industry providing oversight to manufacturing operations; 0-2 with a Master's degree.
  • Ability to translate complex issues into a meaningful set of recommendations.
  • Demonstrated knowledge of cGMPs in a manufacturing environment.
  • Strong independent judgement and decision-making abilities.
  • Demonstrated problem detection and problem resolution skills.
  • Must possess good organizational skills.
  • Must possess good verbal and written skills.
  • A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • 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 (includes 2 floating holidays)


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-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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