Senior QC Analyst III — cGMP Quality & Analytics Lead

Meet Life Sciences

Massachusetts

On-site

USD 90,000 - 120,000

Full time

9 days ago

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Job summary

Meet Life Sciences is seeking an experienced QC Analyst III to join our GMP-regulated Quality Control team. The role leads analytical testing across early development to commercial manufacturing, ensuring data integrity and regulatory compliance.

You will work with HPLC/UPLC, GC, UV-Vis, qPCR, ELISA, gel electrophoresis and microscopy, supporting investigations, CAPAs, and regulatory inspections while collaborating with QA, Manufacturing, Development and Project Management.

Qualifications

  • Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
  • 5+ years of experience in a GMP-regulated QC laboratory.
  • Hands-on experience with HPLC, ELISA and qPCR; additional techniques are desirable.
  • Familiarity with GMP, GDP, data integrity and laboratory compliance.
  • Experience with laboratory investigations, troubleshooting and CAPAs.
  • Strong technical writing skills for SOPs, methods, protocols and reports.

Responsibilities

  • Perform routine and non-routine testing of raw materials, in-process samples, stability samples, and finished products.
  • Conduct analytical testing using HPLC/UPLC, GC, UV-Vis, qPCR, ELISA, gel electrophoresis, microscopy and related methods.
  • Support environmental monitoring and raw material testing.
  • Review and verify laboratory data in accordance with GMP and data integrity requirements.
  • Author and revise SOPs, analytical methods, protocols, specifications and technical reports.
  • Lead and support investigations involving deviations, OOS, OOT and CAPAs.
  • Troubleshoot analytical methods, laboratory equipment and testing processes.
  • Maintain accurate laboratory documentation in line with cGMP and GDP.
  • Collaborate with QA, Manufacturing, Development and Project Management; communicate findings to stakeholders.
  • Support regulatory inspections, client audits and quality initiatives; contribute to continuous improvement.

Skills

HPLC/UPLC
GC
UV-Vis
qPCR
ELISA
gel electrophoresis
microscopy
data integrity
technical writing

Education

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences

Job description

Meet Life Sciences is seeking an experienced QC Analyst III to join our GMP-regulated Quality Control team. The role leads analytical testing across early development to commercial manufacturing, ensuring data integrity and regulatory compliance.

You will work with HPLC/UPLC, GC, UV-Vis, qPCR, ELISA, gel electrophoresis and microscopy, supporting investigations, CAPAs, and regulatory inspections while collaborating with QA, Manufacturing, Development and Project Management.

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