Quality Control Analyst II

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

Full time, permanent

Onsite 5 days

No sponsorship provided

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.

• 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.

• 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.