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QC Analyst

Company:
The Steely Group
Location:
Woburn, MA, 01801
Posted:
June 06, 2025
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Description:

Our client is seeking a highly motivated Entry-Level Quality Control (QC) Analyst to join the Gene Therapy QC Bioassay group. This is an excellent opportunity for recent graduates or individuals early in their careers to gain hands-on experience in a dynamic and cutting-edge environment supporting AAV-based gene therapy programs. The QC Analyst will be trained to perform cell-based bioassays, ELISAs, and other biological methods in a GMP-regulated setting, while also supporting external laboratory testing.

Responsibilities:

Learn and perform immunoassays (e.g., ELISA) and cell-based assays under supervision in a GMP environment to support product release and stability testing.

Assist in drafting and reviewing standard operating procedures (SOPs) and technical documents.

Support method transfer, qualification of critical reagents, and other assay-related activities.

Participate in the review and basic trending of QC data.

Assist with routine laboratory upkeep, including cell culture maintenance, instrument calibration, and inventory tracking.

Collaborate with internal teams and external partners as part of cross-functional project support.

Contribute to investigations and deviation reports under guidance.

Requirements / Qualifications:

Bachelorâ s degree in Cell Biology, Molecular Biology, Biochemistry, or a related scientific field.

Academic or internship experience with mammalian cell culture and/or ELISAs strongly preferred.

Familiarity with basic lab techniques and data analysis methods.

Enthusiasm for learning and the ability to work both independently and within a team.

Strong organizational, communication, and interpersonal skills.

Detail-oriented and eager to develop problem-solving skills in a regulated lab environment.

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