Sr. Specialist, Quality Control

The Role

Moderna is looking for a Senior Quality Control Specialist for their Marlborough, MA location. This role involves maintaining and supporting the life cycle of QC equipment, as well as providing training support. The specialist will collaborate with various teams to achieve company goals and might also assist in investigating Quality Events.

Here’s What You’ll Do

• Track and report on the status of instrument life cycles, including acquisition, relocation, decommissioning, and qualification activities, using project management tools.

• Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors.

• Assist with quality systems records such as deviations, change controls, CAPAs as required.

• Support efforts for method troubleshooting remediation, change, and optimization efforts in cross-functional teams.

• Write, revise, and manage standard operating procedures (SOPs) for equipment, instruments, and training.

• Perform data entry, analysis, trending, and review.

• Assist in the streamlined onboarding of new Quality Control staff.

• Collaborate with management/peers and coordinate all required training for current and future staff.

• Provide feedback to management on developmental status of new staff during training sessions.

• Coordinate with the Quality Assurance training group to create, maintain, and update all required training documentation, including on-the-job training, training materials, and instructor-led training sessions.

• Instruct staff on general laboratory support tasks such as preparing reagents, managing samples, maintaining equipment, and general lab upkeep.

• Maintain cGMP documentation for work performed.

• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Complete training in the assigned required learning plan according to the defined timing and the prescribed requalification cadence.

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

• Bachelor's degree in a relevant scientific discipline.  

• 6-8 years of experience in a cGMP Quality Control environment

• Ability to understand GxP regulations.  

• Desire to impact a high-growth, transformational company with a bold, relentless, curious, and collaborative culture.  

Desired Attributes:  

• Strong leadership and management skills.  

• Excellent communication and interpersonal skills.  

• Problem-solving and troubleshooting abilities.  

• Ability to work collaboratively across departments.  

• Commitment to safety and quality.  

• Vision for continuous improvement and innovation.  

• Strategic thinking aligned with organizational goals.  

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