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 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. #J-18808-Ljbffr