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Sr. Quality Assurance Specialist

3 months ago

Norwood, United States Randstad Life Sciences US Full time

6 Month Contract

Norwood, MA (open to hybrid schedule after training)

PR: $45-55/hour

Job Summary

The Quality Assurance Sr. Specialist is based in Norwood, MA. This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide quality oversight of Quality Control, with a focus on reviewing the following types of documents in support of QC and AS&T: protocols, reports, method SOPs, forms, OJTs, and data tables. The individual will work closely with Quality Control, AS&T, Manufacturing, and other teams.


Job Responsibilities

  • Reviews and approves protocols, reports, method SOPs, forms and data tables generated by the Analytical Science and Technology (AS&T) department to ensure compliance and adherence to regulations and cGMP operations.
  • Reviews and approves Quality Control (QC) method qualification protocols and reports.
  • Reviews and approves Quality Control Stability Protocols and Reports.
  • Participates in weekly and monthly walk-throughs to ensure compliance in the laboratories.
  • Reviews QC logbooks and alarm responses.
  • Works closely with QA teammates to recognize opportunities for improvement within QC.
  • Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Executes tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  • Follows Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Participates in quality oversight of Quality Control and AS&T.


Education & Qualifications

Required

  • Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
  • 7 – 10 years’ experience within a Quality role at a GMP manufacturing environment (combination of Quality Assurance and Quality Control experience preferred).
  • Demonstrated strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).

Preferred

  • Knowledge of Veeva electronic Document Management System (or equivalent).
  • Ability to use and navigate Word, Excel, PowerPoint, and Smartsheets.
  • Working knowledge of relevant EU and global regulations and ICH related to GxP’s.
  • Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
  • Ability to conceptualize, analyze, plan, and manage multiple projects in a fast-paced environment.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.