The Role: ModernaTX, Inc. 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 Bring to the Table:Minimum requirements: - 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.
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 individual's 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 [redacted] with subject line: R19408.
