Cell & Gene Therapy QC Associate

About the Job

Title: Cell & Gene Therapy QC Associate

Location: Boston, MA (Onsite)

Employment Type: Contract (12 Months)

Schedule: Sunday – Wednesday

Shift: 7:30 AM – 6:00 PM

Status: Accepting Candidates

About the Role

We are seeking a Sr QC Associate, Cell Therapy to support Quality Control testing activities within a fast-paced cell therapy manufacturing environment. This role will be responsible for performing in-process, release, and stability testing of cell therapy products while ensuring compliance with GMP standards and regulatory requirements. The ideal candidate will have laboratory experience in biologics or cell and gene therapy, strong aseptic technique skills, and familiarity with analytical testing methods used in QC operations.

Key Responsibilities

Quality Control Testing

• Perform QC testing of cell therapy in-process, release, and stability samples.
• Execute analytical methods including flow cytometry, qPCR, ELISA, cell counting, sterility, gram stain, and endotoxin testing.
• Analyze and document test results in accordance with laboratory procedures and quality standards.
• Conduct technical reviews of raw data and ensure accuracy and completeness of records.

Documentation & Data Management

• Maintain accurate laboratory notebooks, electronic records, and supporting documentation.
• Record, review, and archive test results following cGMP and cGDP requirements.
• Assist in tracking, trending, and reporting QC data.
• Support investigations and documentation activities as needed.

Laboratory Operations

• Perform routine laboratory maintenance and equipment upkeep.
• Ensure laboratory materials and supplies are properly maintained and available.
• Follow established laboratory procedures and safety guidelines.
• Support continuous improvement initiatives within the QC laboratory.

Compliance & Quality

• Adhere to cGMP, cGDP, and company quality standards.
• Maintain compliance with applicable regulatory requirements.
• Support audit readiness and inspection-related activities.
• Promote a culture of quality, safety, and operational excellence.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Biochemistry, Biotechnology, or a related scientific discipline.
• 1 years of laboratory, Quality Control, or biologics testing experience.
• Experience working in a GMP-regulated environment preferred.
• Knowledge of cell therapy, biologics, or cell and gene therapy (CGT) products preferred.
• Experience with laboratory techniques such as:
• Flow Cytometry
• qPCR
• ELISA
• Cell Counting
• Sterility Testing
• Endotoxin (LAL) Testing
• Strong aseptic technique experience required.
• Excellent attention to detail and documentation skills.
• Strong communication, teamwork, and problem-solving abilities.

Preferred Qualifications

• Experience in Cell & Gene Therapy (CGT) environments.
• Familiarity with MycoTOOL, BACT, or other microbiological testing methods.
• Experience reviewing laboratory data and supporting investigations.
• Understanding of stability testing and release testing processes.

Compensation

Massachusetts Pay Transparency:

• Estimated Pay Rate: $25–$30/hour (W-2)
• Final compensation will be based on experience, qualifications, and interview performance.