QC Analyst II

Main Tasks & 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
• Gas Chromatography (GC)
• UV-Visible Spectroscopy
• qPCR
• Gel Electrophoresis
• 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:
• Standard Operating Procedures (SOPs)
• Test methods
• Validation and qualification protocols
• Technical reports
• 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.

Skills & Experience

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline required.
• Minimum of 3 years of experience in a GMP Quality Control laboratory environment.
• 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, which requires five days per week at our Watertown, MA location.
• Annual Base Salary Range - $80,000 - $90,000

URL to this page