Senior QC Materials Specialist — GMP/Onsite Lead

Moderna Inc.

Norwood (MA)

On-site

USD 90,000 - 130,000

Full time

4 days ago
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Benefits offered by this job

Healthcare
Well-being programs
Family planning benefits
Paid time off
Year-end shutdown
Savings plan

Job summary

Moderna Inc. is seeking a QC professional to oversee raw material activities in a GMP environment. This 1st shift role requires hands-on testing, documentation, and collaboration with internal and external labs to ensure material release and data integrity.

You will lead QA procedures, participate in deviations and CAPAs, and support regulatory inspections while maintaining a safe, compliant lab culture onsite.

Qualifications

  • BS in a scientific discipline with GMP QC exposure.
  • 6+ years with BS or 8+ years in GMP QC laboratory setting.
  • Strong understanding of GxP.
  • Regulatory knowledge and problem-solving skills.

Responsibilities

  • Prioritize and release raw materials to meet metrics and turnaround times.
  • Review raw data, supplier certification, and documentation to meet requirements.
  • Perform specification reviews and approvals.
  • Support continuous improvement of lab operations.
  • Lead projects with defined deliverables and timelines.
  • Audit support during regulatory inspections.

Skills

GxP knowledge
Regulatory compliance
Problem solving
Quality systems
Documentation

Education

BS in a scientific discipline

Tools

LIMS (LabVantage)

Job description

Moderna Inc. is seeking a QC professional to oversee raw material activities in a GMP environment. This 1st shift role requires hands-on testing, documentation, and collaboration with internal and external labs to ensure material release and data integrity.

You will lead QA procedures, participate in deviations and CAPAs, and support regulatory inspections while maintaining a safe, compliant lab culture onsite.

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