The Role
Moderna seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location.
Here’s What You’ll Do
- Oversee Quality Control (QC), review Standard Operating Procedures (SOPs), and 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 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.
- 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, and review records using Veeva, Osi Pi, Maxima, and Smartsheet.
- Participate in internal audits for compliance with SOPs, GMPs, and regulations.
- Must be available to work rotating shifts (evenings/weekends/holidays) as needed.
Here’s What You’ll Need (Basic Qualifications)
- Requires a Master’s degree, or foreign equivalent, in Engineering Management, Engineering (any), Biology, Chemistry, or related field and 3 years of experience as a Quality Assurance Associate, QA Testing Engineer, Supervising Engineer, Graduate Apprentice, or related position.
- Must have 3 years of experience with the following:
- Writing and ensuring compliance to SOPs;
- Documenting processes, deviations, and corrective actions to maintain quality records;
- Root Cause Analysis;
- Technical writing; and
- Smartsheet.
- Must also have experience with: Applying knowledge of GxP regulations including GMP, GLP, GCP, & GVP; and cGMP compliance procedures.
- Must be available to work rotating shifts (evenings/weekends/holidays) as needed.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
- Competitive healthcare, 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
- Savings and investments to help you plan for the future
- Location-specific perks and extras
The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
