Sr. Specialist, Quality Assurance

The Role:

Moderna is seeking a Senior Specialist to support Quality on The Floor (OTF) team.  This team provides oversight of manufacturing activities and Facilities at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA.  The main responsibility for this position will be to provide additional support to the QA OTF by scheduling or providing training, provide quality oversight of manufacturing and Facilities, with a focus on deviations, change controls, CAPAs, and method qualifications/validations as needed across the shifts. This position will support metrics establishment, shift change, Tier development, and other communications as required for QA OTF.  This position will be both tactical and strategic as we work to onboard new employees and ramp the manufacturing process.  Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with managers, specialists, and others from Manufacturing, Quality Control, Quality, and Facility teams.

Here’s What You’ll Do:

• Establish/support key metrics for QA OTF

• Support shift change, tier development, and other communications throughout the team

• Support scheduling and tracking training for new QA OTF employees

• Provide additional support for quality on-the-floor managers and specialists including provide support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs, as needed

• Support quality decisions that may impact operations, ensuring appropriate escalation.

• Identify risks and communicate gaps for quality and GMP process/systems.

• Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.

• Supports, reviews and approves Deviations and change controls

• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.

• Collaborate with Manufacturing to resolve equipment and process issues

• Identify continuous improvement opportunities and spearhead changes

• Support internal audits.

• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

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

• BS with 6+ years of experience, or a Master’s level degree with at least 4 years’ experience in the pharmaceutical/biotech industry.

• Highly organized, good written and communication skills, detail oriented

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
  •    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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.