Senior QC Data Review Analyst - cGMP & Data Integrity

The Steely Group; Woburn (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

The Steely Group in Woburn, MA seeks a Senior QC Analyst I, Data Review to join the Gene Therapy Quality Control organization. The role focuses on reviewing analytical data from internal and external laboratories to support AAV programs.

You will ensure data integrity, cGMP compliance, and timely product disposition by performing comprehensive data review, trend analysis, and collaboration with QA teams and CTOs.

Qualifications

• Degree in life sciences with 5+ years in GMP/GLP environments.
• Experience reviewing analytical data from multiple platforms (qPCR, ELISA, HPLC, electrophoresis).
• Strong data integrity, ALCOA+ principles, and cGMP knowledge.

Responsibilities

• Perform comprehensive review and approval of cGMP analytical data for release, stability, and characterization.
• Verify data accuracy, completeness, and adherence to methods and regulatory requirements.
• Review raw data, notebooks, and metadata; support investigations and CAPAs.
• Generate data quality metrics and contribute to continuous improvement.
• Support regulatory inspections with analytical documentation.

Education

BS or MS in Cell Biology, Molecular Biology, Biochemistry or related discipline

Tools

LIMS (LabVantage)

ELN

CDS

Empower

SoftMax Pro

JMP

QuantaSoft

Job description

The Steely Group in Woburn, MA seeks a Senior QC Analyst I, Data Review to join the Gene Therapy Quality Control organization. The role focuses on reviewing analytical data from internal and external laboratories to support AAV programs.

You will ensure data integrity, cGMP compliance, and timely product disposition by performing comprehensive data review, trend analysis, and collaboration with QA teams and CTOs.