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.
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:
·Ability to communicate effectively, both in writing and orally. Strong English verbal and written communication skills required. Ability to accurately read, interpret, and produce technical documentation.
·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.
Conditions of Employment:
·Strong English verbal and written communication skills required, with the ability to accurately read, interpret, and produce technical documentation
How to Apply:
For full consideration, please submit the following document(s):
1.A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2.Curriculum vitae / Resume
3.Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Applications are accepted electronically ONLY at www.cu.edu/cu-careers
Questions should be directed to: Chris Freedman, Christopher.freedman@cuanschutz.edu
Screening of Applications Begins:
Immediately and continues until July 27, 2026
Anticipated Pay Range:
Thehiring range for this position has been established at: $25.00 to $35.00 / hour. The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty, and training.
Your total compensation goes beyond the number on your paycheck. Temporary employees are only eligible for sick leave benefits.
Equal
Employment Opportunity Statement:
The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu.
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in theoccupational health medical surveillance program
