Senior QC Analyst - GMP & Data Integrity Lead

Meet Life Sciences; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Meet Life Sciences seeks a hands-on QC Analyst III to join our Quality Control team in a GMP-regulated environment. You will lead analytical testing across raw materials, in-process samples, stability programs and finished products, ensuring compliance with cGMP, GDP and data integrity standards.

You will collaborate with QA, Manufacturing, Development and Project Management to deliver accurate results, author SOPs, investigate deviations, and drive continuous improvement in testing quality and

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• 5+ years of experience working within a GMP-regulated Quality Control laboratory environment.
• Hands-on experience with HPLC, ELISA and qPCR.
• Experience with UPLC, GC, UV-Vis, gel electrophoresis and microscopy is desirable.
• Strong understanding of cGMP, GDP, data integrity and laboratory compliance requirements.
• Experience within a CDMO, CMO, pharmaceutical or biotech manufacturing environment is preferred.

Responsibilities

• Perform routine and non-routine analytical testing of raw materials, in-process samples, stability samples and finished products.
• Execute analytical testing using HPLC/UPLC, GC, UV-Vis, qPCR, ELISA, gel electrophoresis, microscopy and other relevant methodologies.
• Maintain complete and accurate laboratory records in accordance with cGMP and GDP.
• Lead and participate in laboratory investigations, including deviations, OOS, OOT and CAPA activities.
• Author, review and update SOPs, analytical methods, protocols, specifications and technical reports.
• Collaborate with Manufacturing, Quality Assurance, Development and Project Management to support client requirements.

Skills

HPLC

ELISA

qPCR

Data integrity

Attention to detail

Troubleshooting

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or a related scientific discipline

Tools

HPLC/UPLC equipment

GC

UV-Vis

Microscopy

Gel electrophoresis

Job description

Meet Life Sciences seeks a hands-on QC Analyst III to join our Quality Control team in a GMP-regulated environment. You will lead analytical testing across raw materials, in-process samples, stability programs and finished products, ensuring compliance with cGMP, GDP and data integrity standards.

You will collaborate with QA, Manufacturing, Development and Project Management to deliver accurate results, author SOPs, investigate deviations, and drive continuous improvement in testing quality and