Sample Management Coordinator at The Steely Group in Woburn, Massachusetts

Job Description:

Reporting to the Associate Director, QC Sample Management, the QC Sample Management Coordinator will support the gene therapy program pipeline including but not limited to routine GMP sample management activities related to both internal and external manufacturing/testing.

Adaptable to perform in a fast-paced environment while still delivering high-quality results, this QC Sample Management Coordinator will be required to have strong interpersonal skills, and organization skills with a high attention to detail.

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.

Requirements / 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
• Competent computer skills including Microsoft Office
• Ability to work in a fast-paced work environment

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