Temporary Data Reviewer
About The Position
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.
Requirements
- 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.
- Strong English verbal and written communication skills required, with the ability to accurately read, interpret, and produce technical documentation
Nice To Haves
- Experience developing GMP QA systems specifically batch release and disposition.
- Knowledge of FDA cGMP regulations, FACT standards, and GMP documentation practices.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
- Highly self-motivated and organized, with the ability to work both independently and collaboratively in a fast-paced, team-oriented environment.
- Technical writing ability to draft and edit controlled documents such as SOPs, Work Instructions (WIs), and forms.
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
Benefits
- sick leave
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What This Job Offers
Career Level
Mid Level
