Quality Control Analyst III

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

We are seeking a highly motivated QC Analyst III to join the Quality Control team within a GMP-regulated environment. This position will play an important role in supporting quality control activities from early-stage development through commercial manufacturing.

The QC Analyst III will be responsible for executing and leading analytical testing while ensuring compliance with cGMP requirements, regulatory expectations, data integrity standards and internal quality procedures. The role will support testing across raw materials, in-process materials, finished products, stability programs and environmental monitoring.

You will work closely with Quality Assurance, Manufacturing, Development and Project Management teams to ensure accurate, timely and compliant analytical results. The position will also contribute to laboratory investigations, analytical troubleshooting, technical documentation and continuous improvement initiatives.

Key Responsibilities

• Perform routine and non-routine analytical testing of raw materials, in-process samples, stability samples and finished products.
• Execute analytical testing using techniques including HPLC/UPLC, GC, UV-Vis, qPCR, ELISA, gel electrophoresis, microscopy and other relevant methodologies.
• Support raw material testing and environmental monitoring activities.
• Accurately document, review and verify laboratory data in accordance with GMP and data integrity requirements.
• Author, review and update SOPs, analytical methods, protocols, specifications and technical reports.
• Lead and participate in laboratory investigations, including deviations, OOS, OOT and CAPA activities.
• Troubleshoot analytical methods, laboratory equipment and testing processes, implementing improvements where appropriate.
• Maintain complete and accurate laboratory records in accordance with cGMP and Good Documentation Practices (GDP).
• Partner cross-functionally with Manufacturing, Quality Assurance, Development and Project Management to support operational and client requirements.
• Communicate analytical results, technical findings and quality-related issues clearly to internal stakeholders.
• Support regulatory inspections, client audits and quality initiatives.
• Contribute to continuous improvement projects designed to improve laboratory efficiency, compliance, testing quality and turnaround times.
• Support training and knowledge sharing within the QC laboratory as required.
• Perform other duties and responsibilities as assigned.

Skills & Experience

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or a related scientific discipline.
• 5+ years of experience working within a GMP-regulated Quality Control laboratory environment.
• Strong hands-on experience with HPLC, ELISA and qPCR.
• Experience with UPLC, GC, UV-Vis, gel electrophoresis and microscopy is highly desirable.
• Demonstrated experience with laboratory investigations, troubleshooting, deviations, OOS/OOT results and CAPAs.
• Strong understanding of cGMP, GDP, data integrity and laboratory compliance requirements.
• Knowledge of applicable FDA, ICH and EU regulatory requirements and guidance.
• Experience within a CDMO, CMO, pharmaceutical or biotech manufacturing environment is preferred.
• Strong technical writing skills, including experience developing or revising SOPs, analytical methods, protocols and technical reports.
• Excellent attention to detail and a strong commitment to data accuracy and documentation integrity.
• Strong analytical and problem-solving skills, with the ability to investigate issues, analyse data and draw sound conclusions.
• Ability to work independently while collaborating effectively within a fast-paced, cross-functional environment.
• Strong organisational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent written and verbal communication skills.

What We're Looking For

The ideal candidate will be a hands-on QC professional who combines strong analytical laboratory skills with sound GMP knowledge and a proactive approach to problem solving. You should be comfortable taking ownership of testing activities, investigating laboratory issues and working cross-functionally to ensure high-quality results and reliable product delivery.

Experience in a client-focused CDMO or pharmaceutical/biotech manufacturing environment will be particularly valuable.