Specialist, Quality Assurance

Moderna•Norwood, MA

2d•$89,900 - $143,800•Onsite

About The Position

ModernaTX, Inc. seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location. This role involves overseeing Quality Control (QC), reviewing Standard Operating Procedures (SOPs), and ensuring current Good Manufacturing Practice (cGMP) compliance. The Specialist will manage and review documentation, investigations, deviations, equipment alarms, and laboratory events from QC departments. They will contribute to continuous improvement, participate in internal audits, and create/establish processes and procedures to ensure compliance with regulations and cGMP operations. The role requires making quality decisions that may impact operations, ensuring appropriate escalation to management, and supporting QC lab investigations including managing, reviewing, and approving deviations, change controls, and CAPA. Additionally, the Specialist will review and approve QC alarms, perform routine walkthroughs of QC labs, and support reviewing/approving QC work order requests and Out of Trend (OOT) records. Review and approval of Laboratory Events and Out of Scope (OOS) Laboratory Investigations, method qualification protocols and reports, SOPs, forms, document change control, and deviations are also key responsibilities. The role utilizes Veeva, Osi Pi, Maxima, and Smartsheet. Participation in internal audits for compliance with SOPs, GMPs, and regulations is expected. Availability for rotating shifts (evenings/weekends/holidays) is required.

Requirements

Master’s degree, or foreign equivalent, in Engineering Management, Engineering (any), Biology, Chemistry, or related field
3 years of experience as a Quality Assurance Associate, QA Testing Engineer, Supervising Engineer, Graduate Apprentice, or related position
3 years of experience with writing and ensuring compliance to SOPs
3 years of experience documenting processes, deviations, and corrective actions to maintain quality records
3 years of experience with Root Cause Analysis
3 years of experience with Technical writing
3 years of experience with Smartsheet
Experience applying knowledge of GxP regulations including GMP, GLP, GCP, & GVP
Experience with cGMP compliance procedures
Must be available to work rotating shifts (evenings/weekends/holidays) as needed

Nice To Haves

Experience using Veeva, Osi Pi, and Maxima

Responsibilities

Oversee Quality Control (QC)
Review Standard Operating Procedures (SOPs)
Ensure current Good Manufacturing Practice (cGMP) compliance
Manage and review documentation, investigations, deviations, equipment alarms, and laboratory events from QC departments
Contribute to continuous improvement
Participate in internal audits to maintain regulatory compliance
Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations
Make quality decisions that may impact operations, ensuring appropriate escalation to management
Support QC lab investigations including managing, reviewing, and approving deviations, change controls, and CAPA
Review and approve QC alarms
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 Laboratory Events and Out of Scope (OOS) Laboratory Investigations
Review and approve method qualification protocols and reports, SOPs, forms, document change control, and deviations
Participate in internal audits for compliance with SOPs, GMPs, and regulations

Benefits

Best-in-class healthcare coverage
Voluntary benefit programs
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
Savings and investment opportunities
Location-specific perks and extras
Annual discretionary bonus (potential eligibility)
Other incentive compensation (potential eligibility)
Equity award (potential eligibility)