Quality Control Analyst II

Meet Life Sciences; Watertown (MA); On-site; USD 75,000 - 95,000; Full time

Job summary

Meet Life Sciences is seeking a QC Analyst II to support environmental monitoring within GMP manufacturing in Watertown, MA. You will join a collaborative Quality Unit and work closely with Manufacturing, Quality Assurance, and Development teams.

The role emphasizes data integrity, investigation of quality events, and continuous improvement, with hands-on lab work in a fast-paced CDMO environment. Onsite, full-time position based in Watertown.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 3+ years of GMP QC experience.
• Hands-on experience with microbiological techniques in a regulated pharma/biotech lab.
• Strong knowledge of cGMP, data integrity, and deviation handling.
• Experience supporting continuous improvement in a fast-paced CDMO environment.
• Excellent organizational and communication skills with attention to detail.

Responsibilities

• Perform routine environmental monitoring sampling and testing in GMP manufacturing areas.
• Review data, generate trend reports, perform growth promotion studies, and document in compliance with cGMP.
• Support QC activities including raw material testing and maintain lab records.
• Initiate investigations of deviations and OOS events; assist with troubleshooting and improvements.
• Draft and revise SOPs, test methods, and reports; communicate results to cross-functional teams.

Skills

Communication

Problem-solving

Attention to detail

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Microbiological techniques

Job description

QC Analyst II for well-established CDMO broadly supporting pharma and biotech in Watertown, MA

Full time, permanent

Onsite 5 days

No sponsorship provided

Company & Role Overview

Join a growing contract development and manufacturing organization (CDMO) supporting pharmaceutical and biotechnology companies from early-stage development through commercial manufacturing. As a QC Analyst II – Environmental Monitoring, you will play a critical role in ensuring GMP compliance by performing environmental monitoring and quality control testing that supports the production of high-quality therapeutics. Working within a collaborative Quality Unit, you'll partner closely with Manufacturing, Quality Assurance, and Development teams to maintain data integrity, investigate quality events, and support continuous improvement initiatives. This position offers a hands-on laboratory environment with opportunities to expand your technical expertise while contributing to a fast-paced, client-focused organization. This is a full-time, onsite position based in Watertown, MA.

Job Duties

• Perform routine environmental monitoring sampling and testing within GMP manufacturing areas, including facility water (WFI), clean steam, and microbiological monitoring activities.
• Review environmental monitoring data, generate trend reports, execute growth promotion studies, and ensure accurate documentation in compliance with cGMP and GDP requirements.
• Support quality control activities including raw material testing while maintaining laboratory records and ensuring data integrity across all testing activities.
• Initiate and participate in laboratory investigations, deviations, and out-of-specification (OOS) events while assisting with troubleshooting and continuous improvement initiatives.
• Author and revise SOPs, test methods, protocols, and reports while collaborating cross-functionally with Manufacturing, Quality Assurance, and Project Management teams to communicate results and support client programs.

Job Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 3+ years of experience in a GMP Quality Control environment.
• Hands-on experience with microbiological techniques and environmental monitoring in a regulated pharmaceutical or biotechnology laboratory.
• Strong understanding of cGMP regulations, laboratory documentation practices, data integrity, and quality investigations, including deviations and OOS events.
• Experience supporting continuous improvement initiatives and working collaboratively in a fast-paced, client-driven manufacturing or CDMO environment is preferred.
• Excellent organizational, communication, and problem-solving skills, with the ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail.