Title: QC Specialist (Cell Therapy / GMP Laboratory)

Location: Boston, MA (100% Onsite)

Employment Type: Contract (6+ Months)

Status: Accepting Candidates

About the Role

We are seeking a Quality Control Specialist to support analytical testing for in-process, release, and stability samples within a cGMP Quality Control laboratory.

This position supports cell and gene therapy manufacturing by performing laboratory testing, reviewing analytical data, maintaining laboratory records, and supporting quality events in a highly regulated environment.

Key Responsibilities

Quality Control Laboratory Testing

Perform analytical testing including:
• Flow Cytometry
• Cell Counting
• Cell Culture
• Sterility Testing (BACT)
• Endotoxin Testing (LAL)
• Visual Inspection
• Support in-process, release, and stability testing

Laboratory Operations

Perform technical review of analytical data

Maintain laboratory notebooks and raw data

Record test results in electronic laboratory systems

Perform routine laboratory equipment maintenance

Quality & Compliance

Support investigations involving:
• Deviations
• OOS (Out-of-Specification)
• Quality Events

Troubleshoot laboratory methods

Maintain compliance with:
• cGMP
• cGDP
• Support laboratory documentation requirements

Qualifications

Education

Bachelor's Degree in:
• Biology
• Chemistry
• Biochemistry
• Microbiology
• Related Life Science

Required Experience
• 4–6 years of GMP Pharmaceutical or Biopharmaceutical Quality Control experience
• Experience performing multiple laboratory techniques including:
• Flow Cytometry
• Cell Culture
• Cell Counting
• Sterility Testing
• Endotoxin Testing
• Experience reviewing analytical data
• Experience with LIMS or Electronic Laboratory Notebook systems
• Strong understanding of cGMP laboratory operations

Preferred Qualifications
• Cell Therapy experience
• Gene Therapy experience
• Flow Cytometry expertise
• BACT systems experience
• LAL testing
• Stability testing
• Technical troubleshooting experience
• Experience with Quality Events

Compensation
• $35–48/hr W2
• Duration: 6+ Months
• Shift: Wednesday – Saturday 12:30 PM – 11:00 PM
• Location: Boston, MA 100% Onsite