Specialist, Quality Assurance

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 processes 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 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. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #J-18808-Ljbffr BioSpace