GMP QC Sample Coordination Specialist

The Steely Group; Woburn (MA); On-site; USD 42,000 - 62,000; Full time

Job summary

The Steely Group in Woburn, MA is seeking a QC Sample Management Coordinator to support the gene therapy program pipeline. You will manage GMP samples, coordinate shipments, and ensure compliant documentation and disposal.

You will collaborate with internal teams and external labs, maintaining strict adherence to SOPs and cGMP. Ideal candidates have 0–2 years in GMP and an eye for detail.

Qualifications

• Associates or Bachelors degree in a scientific discipline preferred.
• 0-2 years of related work experience in a GMP environment.
• Experience with aseptic technique skills/knowledge a plus.
• Ability to work in a fast-paced work environment.

Responsibilities

• Executes all aspects of Quality Control Sample Management in support of GMP Drug Substance and Drug Product manufacturing including, but not limited to, incoming sample receipt, sample aliquoting, sample transactions in LIMS, sample distribution to testing laboratories and sample disposal.
• Coordinate shipments of samples to external testing laboratories, as required.
• Supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management).
• Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
• Properly handles, stores, and disposes of hazardous materials according to OSHA and company procedures.
• Ensures all work performed strictly adheres to UGT SOPS and cGMP requirements.
• Follows good documentation practices, all safety rules and regulations.

Skills

GMP environment

Aseptic technique

Attention to detail

Organizational skills

Interpersonal skills

Education

Associates or Bachelor's degree in a scientific discipline

Tools

LIMS

Job description

The Steely Group in Woburn, MA is seeking a QC Sample Management Coordinator to support the gene therapy program pipeline. You will manage GMP samples, coordinate shipments, and ensure compliant documentation and disposal.

You will collaborate with internal teams and external labs, maintaining strict adherence to SOPs and cGMP. Ideal candidates have 0–2 years in GMP and an eye for detail.