About the Role

We are seeking a highly motivated QC Analyst III to join our Quality Control team in a GMP-regulated environment. This role is responsible for performing and leading quality control activities that support programs from early-phase development through commercial manufacturing. As a key member of the Quality Unit, the QC Analyst III will ensure compliance with cGMP requirements and regulatory standards while supporting in-process, release, stability, raw material, and environmental monitoring testing.

The successful candidate will work collaboratively with Development, Manufacturing, Quality Assurance, and Project Management teams to ensure product quality, data integrity, and timely delivery of analytical results in a fast-paced CDMO environment. This position also plays a critical role in laboratory investigations, troubleshooting activities, technical documentation, and continuous improvement initiatives.

Main Tasks & Responsibilities

  • Perform routine and non-routine analytical testing of raw materials, in-process samples, stability samples, and finished products.
  • Execute analytical assays utilizing techniques such as UPLC, GC, UV-Vis, qPCR, gel electrophoresis, microscopy, and other relevant methodologies.
  • Support raw material testing and environmental monitoring activities.
  • Accurately record, review, and verify laboratory data in compliance with GMP and data integrity requirements.
  • Author, review, and revise Standard Operating Procedures (SOPs), analytical methods, protocols, specifications, and technical reports.
  • Lead and participate in laboratory investigations, including deviations, out-of-specification (OOS) results, out-of-trend (OOT) results, and corrective/preventive actions (CAPAs).
  • Troubleshoot analytical methods, laboratory equipment, and testing processes; recommend and implement improvements as needed.
  • Maintain laboratory documentation and records in accordance with cGMP and Good Documentation Practices (GDP).
  • Collaborate cross-functionally with Manufacturing, Quality Assurance, Development, and Project Management teams to support operational and client needs.
  • Clearly communicate testing results, technical findings, and quality-related issues to internal stakeholders.
  • Support regulatory inspections, client audits, and quality initiatives as required.
  • Contribute to continuous improvement efforts that enhance laboratory efficiency, compliance, and quality systems.
  • Perform other duties as assigned.

Skills & Experience

  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
  • Minimum of 5 years of experience in a GMP-regulated Quality Control laboratory environment.
  • Demonstrated hands-on experience with analytical techniques such as HPLC, ELISA, and qPCR; experience with UPLC, GC, UV-Vis, gel electrophoresis, and microscopy is highly desirable.
  • Proven experience supporting laboratory investigations, troubleshooting activities, and continuous improvement initiatives.
  • Strong understanding of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and laboratory compliance requirements.
  • Familiarity with FDA, ICH, and EU regulatory requirements and guidance documents.
  • Experience within a Contract Development and Manufacturing Organization (CDMO) or Contract Manufacturing Organization (CMO) environment is preferred.
  • Strong technical writing skills with experience authoring and revising SOPs, methods, protocols, and reports.
  • Excellent documentation practices and commitment to data integrity principles.
  • Strong attention to detail with exceptional analytical and problem-solving abilities.
  • Ability to define problems, collect and analyze data, establish facts, and draw sound conclusions.
  • Self-motivated and capable of working independently in a fast-paced, client-focused environment.
  • Demonstrated ability to manage multiple priorities, meet deadlines, and adapt to changing business needs.
  • Strong verbal and written communication skills, with the ability to effectively collaborate across functional teams.

Work Environment

This position is fully on-site and requires five days per week at our Watertown, MA location.

Annual Base Salary Range: $90,000 - $100,000

 

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