About the Role

We are seeking a detail-oriented and highly motivated QC Analyst II to join our growing Quality Control team. This role is responsible for supporting early-phase development through commercial manufacturing activities within a GMP-regulated environment. 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.

As a key member of the Quality Unit, the successful candidate will support in-process, release, stability, raw material, and environmental monitoring testing. This individual will also participate in laboratory investigations, troubleshooting activities, and technical writing efforts while collaborating closely with Manufacturing, Quality Assurance, Development, and Project Management teams in a fast-paced CDMO environment.

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.
  • 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, which requires five days per week at our Watertown, MA location.

Annual Base Salary Range - $80,000 - $90,000

 

 

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