Sr. Specialist, Quality Assurance Validation

The Role:
Reporting to the Supervisor QAV, this person will be responsible for cGMP compliance of process, facility, utilities, equipment, method, 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. equipment qualification, cleaning validation, and computer system validation) 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
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 discrepancies/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.
Participate in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities.
Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
Use critical thinking skills to partner with CQV and facility engineers to problem solve.
Here’s What You’ll Bring to the Table:
Requires a Bachelor’s degree (engineering or scientific discipline) in relevant field
Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight 5-8 years with BS degree, 2-5 years of experience with MS degree or 0-2 years of experience with PhD degree
Experience in IT systems, automation, operations, and manufacturing within the biotechnology industry and in new manufacturing facility startup environment 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 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 demonstrated organizational skills
Must possess excellent verbal and written
Here’s What We’ll Bring to the Table:
Daily on-site catered lunches.
Company-provided iPhone.
Free parking, monthly subway passes 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.
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.
Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:

• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Paid sabbatical after 5 years; every 3 years thereafter
• D iscretionary year-end shutdown

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
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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