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.

• 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.

• 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.

This is a fully on-site role, five days per week at our Watertown, MA location.