Specialist, Quality Assurance Validation

Specialist, Quality Assurance Validation

The Role:

Reporting to the Sr. Manager Quality Assurance, this person will be responsible for cGMP compliance of process, facility, utilities, equipment, method and computer system validation and will be accountable for their execution across the Moderna drug development ecosystem. The role is responsible for ensuring review and approval of all validation records and documentation (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation) are compliant with in-house specifications/standards/procedures and Good Manufacturing Practices.

Here's What You'll Do:

• Provide QA oversight of commissioning, qualification and validation activities to deliver Moderna's new early phase GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods and personalized medicine capabilities.
• Responsible for managing the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
• Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
• Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements.
• Responsible for supporting internal and external inspections as a Subject Matter Expert for Quality Assurance Validation.
• Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Oversight of contractors/consultants in performing similar tasks supporting large projects, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product.

Here's What You'll Bring to the Table:

• Minimum education requirement is a Bachelor's degree, preferably in Sciences or Engineering with 2-5 years of experience. Preferably in Validation.
• Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility startup environments is a plus.
• Demonstrated strong ability in problem solving, strong understanding of cGMPs, excellent interpersonal skills and the ability to prioritize multiple tasks. Uses a team-oriented approach to project management and problem resolution.
• Excellent understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations. Ability to interact effectively with all levels of personnel within the organization.
• Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
• Demonstrate strong organizational skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.

Here's What We'll Bring to the Table:

• 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.

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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.