Moderna is seeking a Sr. Quality Assurance Specialist for a position based at their Norwood, MA facility. The individual in this role will be responsible for providing Quality Assurance (QA) support for Moderna's Clinical Drug Supply Chain packaging, labeling and distribution operations. The individual will primarily work with: Clinical Drug Supply Operations, manufacturing operations, Supply Chain, Internal Quality Assurance and CMC as well as external Vendors including packaging, labeling, distribution and other related service providers to support packaging and labeling activities and the Clinical Supply Chain for Moderna. This individual will support quality oversight for packaging and labeling, batch record review, expiration date management, cold chain and temperature excursion monitoring as well as other key quality assurance activities including supporting quality systems related to the clinical drug supply release and the clinical supply chain. Additionally, this individual may also support clinical drug product batch disposition activities on an ongoing basis. The successful candidate must have experience in a biotech or pharmaceutical GXP environment.
This role may report to the Sr. Manager of Quality Assurance for Clinical Packaging and Labeling and will be responsible for supporting Moderna's clinical packaging, labeling and distribution supply chain.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Review and approve packaging and labeling batch records
- Provide quality oversight of packaging, labeling and distribution vendors
- Review and investigate temperature excursions and manage product impact assessment based on data
- Assist in developing and updating procedures to support late phase and commercial supply chain and distribution operations
- Maintain batch release metrics as well as vendor-based deviations
- Review, assess and track to closure quality systems internally and with packaging and labeling vendors
- Initiate and manage CAPA's to drive proactive initiatives for continuous improvement
- Report temperature excursion data back to clinical partners
- Record and track metrics for key quality performance indicators for cross-functional visibility
- Manage Clinical Supply Chain Quality Deliverable timelines and Provide updates to internal and external customers on a regular basis
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- BS in a scientific or engineering discipline
- 5+ years of experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
- Outstanding / effective communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
- Experience in the drug manufacturing and/or clinical drug packaging and labeling processes
- Proficiency in Microsoft Office tools including Powerpoint, MS Project and Visio
- Previous experience in a GMP environment is required
- 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
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
- 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.