Specialist, Quality Assurance

The Role: ModernaTX, Inc. seeks a Specialist, Quality Assurance for its Norwood, Massachusetts location. Heres What Youll 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. Heres What Youll Bring to the Table: Minimum requirements: Requires a Masters 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. The salary range for this role is $89,900 to $143,800. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $118,435 to $143,800. An individuals placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19408) or email resume and cover letter to careers@modernatx.com with subject line: R19408. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between. 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 Savings and investment opportunities to help you plan for the future Location-specific perks and extras 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. #dni Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. Thats why our benefits and well-being resources are designed to support youat 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 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. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the bodys cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home