Moderna
Specialist, Quality Assurance
Norwood, Massachusetts, USA
Sponsorship not specified$90k-$144kDetected 15 days ago
GCPGMPWritingGxP
About the role
- ModernaTX, Inc. seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location.
- Oversee Quality Control (QC), review Standard Operating Procedures (SOPs), and ensure current Good Manufacturing Practice (cGMP) compliance.
- Make quality decisions that may impact operations, ensuring appropriate escalation to management.
Responsibilities
- Manage and review documentation, investigations, deviations, equipment alarms, and laboratory events from QC departments.
- Contribute to continuous improvement and participate in internal audits to maintain regulatory compliance.
- Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
- Support QC lab investigations including managing, reviewing, and approving deviations, change controls, and CAPA.
- Perform routine walkthroughs of the QC labs.
- Support reviewing and approving, when necessary, QC work order requests, and QC equipment Out of Trend (OOT) records.
- Review and approve method qualification protocols and reports, SOPs, forms, document change control, and deviations, and review records using Veeva, Osi Pi, Maxima, and Smartsheet.
Requirements
- Must have 3 years of experience with the following:
- Must also have experience with: Applying knowledge of GxP regulations including GMP, GLP, GCP, & GVP
- Must be available to work rotating shifts (evenings/weekends/holidays) as needed.
Compensation
- The salary range for this role is $89,900 to $143,800.
Benefits
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Competitive healthcare, plus voluntary benefit programs to support your unique needs
- Location-specific perks and extras
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This listing is sourced directly from Moderna's careers page and normalized into a canonical job model.