QC Analyst II

Overview QC Analyst II to join the Quality Control team in a GMP-regulated environment. This role supports early-phase development through to commercial manufacturing activities. The QC Analyst II will perform a variety of analytical and microbiological testing activities while ensuring compliance with cGMP requirements, regulatory standards, and data integrity principles. Responsibilities Perform routine and non-routine testing of raw materials, in-process samples, stability samples, and finished products. Execute analytical assays using techniques such as UPLC/HPLC, GC, UV-Visible spectroscopy, qPCR, gel electrophoresis, and microscopy. Support raw material testing and environmental monitoring programs. Accurately record, review, and verify laboratory data in compliance with cGMP and GDP requirements. Initiate and participate in laboratory investigations, including deviations, out-of-specification (OOS), and out-of-trend (OOT) results. Troubleshoot analytical methods, instrumentation, and testing processes as needed. Author, revise, and review SOPs, test methods, validation and qualification protocols, technical reports, and laboratory documentation. Maintain accurate and compliant laboratory records in accordance with cGMP requirements. Collaborate cross-functionally with Manufacturing, Quality Assurance, Development, and Project Management teams. Clearly communicate testing results, quality concerns, and project updates to stakeholders. Contribute to continuous improvement initiatives and laboratory efficiency projects. Perform other duties as assigned. Qualifications Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related scientific discipline required. Minimum of 3 years of experience in a GMP Quality Control laboratory environment. Experience supporting pharmaceutical, biotechnology, cell therapy, gene therapy, or related regulated industries preferred. Prior experience working within a Contract Development and Manufacturing Organization (CDMO/CMO) is highly desirable. Hands-on experience with analytical testing techniques; experience with HPLC, ELISA, and qPCR is strongly preferred. Strong understanding of cGMP, GDP, and quality systems requirements. Experience participating in laboratory investigations, deviations, and CAPA-related activities. Technical writing experience, including SOPs, reports, and controlled documents. Excellent documentation practices and commitment to data integrity. Strong analytical thinking and troubleshooting abilities. Exceptional attention to detail and organizational skills. Effective verbal and written communication skills. Ability to manage multiple priorities and meet deadlines in a fast-paced, client-focused environment. Ability to work independently while contributing to a collaborative team culture. Work Environment This is a fully on-site role, five days per week at our Watertown, MA location. #J-18808-Ljbffr