University of Colorado Anschutz

Department: Gates Institute Biomanufacturing Facility

Job Title: Data Reviewer, Temporary

Position #: 00782556 Requisition#: 40591

This is a Temporary position limited to no more than 9-months.

Job Summary:

The University of Colorado Anschutz medical campus is seeking a temporary Quality Assurance Data Reviewer to join the Gates Biomanufacturing Facility (GBF). GBF is an academic Phase I cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early-phase clinical trials and serves as a core capability that differentiates the university in both regenerative medicine and traditional biotechnology.

Within the Gates Biomanufacturing Facility's dynamic environment, become a contributor to Quality Assurance GMP and non-GMP batch release activities. The QA Data Reviewer will support the review and release of GMP and non-GMP cell therapy and biologic batches, support scanning and archival of GMP and Non-GMP batches, optimize the eQMS batch release system and surrounding SOPs and paper forms, and monitor metrics to ensure batch disposition compliance.

Key Responsibilities:

·         Review Batch Records, In-Process and Release testing data, Chain of Custody forms, Receiving Inspections, Thawing and Infusion documentation related to GMP and Non-GMP batch releases.

·         Scan and archive QA reviewed batch data.

·         Optimize the eQMS batch release system including updating SOPs and paper forms.

·         Monitor batch disposition compliance, metrics, and effectiveness

Work Location:

Onsite - this role is expected to work onsite and is located in Aurora, CO.

Why Join Us:

Join the Gates Biomanufacturing Facility and be part of a team turning cutting-edge science into real therapies for patients. At the GBF, your work directly supports the development and manufacture of novel biologics and cell therapies advancing into early-phase clinical trials, offering a rare opportunity to contribute to life-changing innovation at the intersection of academia and industry.

Qualifications:

Minimum Qualifications:

·         Bachelor's degree in a scientific discipline or related field, or an equivalent combination of education and relevant experience.

·         Minimum of three (3) years of experience data review in a GMP regulated life sciences environment.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

·         Experience developing GMP QA systems specifically batch release and disposition.

·         Knowledge of FDA cGMP regulations, FACT standards, and GMP documentation practices.

Knowledge, Skills and Abilities:

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