Quality Control Analyst I – Data Reviewer/Technical Writer

University of Colorado Anschutz Medical Campus

Department: Gates Biomanufacturing Facility

Job Title:  Quality Control Analyst I – Data Reviewer/Technical Writer

Position #: 803791 – Requisition #:37813

Job Summary:

This position is a full-time, senior-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. This position will be responsible for performing data review for cGMP Quality Control (QC) documentation as well as some development and non-GMP documentation at the Gates Biomanufacturing Facility (GBF). This position will also involve interacting with project management and interfacing with clients. Routine work will also include drafting and reviewing quality events to support batch release for Phase I cell therapy and biotherapeutic products manufactured at GBF. This position requires industrial experience related to performing and reviewing analytical testing in a cGMP Quality Control setting. Extensive experience with deviations and CAPAs in a cGMP setting is also required.

The Gates Biomanufacturing Facility is an academic cGMP contract manufacturing facility dedicated to the development and manufacture of novel biologics and cell therapies for early phase human clinical trials. The Gates Biomanufacturing Facility is one of the core facilities used to differentiate the University in both regenerative medicines as well as traditional biotech streams.

Key Responsibilities:

• Perform a complete data review for all QC cGMP documentation to support batch release

• Perform a complete data review for all cGMP Environmental Monitoring (EM) testing, EM reports, EM excursion events, and growth promotion data

• Perform a complete data review for QC method development and non-GMP experiments including the review of QC notebooks

• Drafting and updating documentation related to the data review process in conjunction with QA.

• Track, collate, draft, and review cGMP QC quality events including deviations, CAPAs, EM excursions, Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations

• Review in-use and completed QC log books

• Oversee the continuous monitoring program and address warnings and excursions related to cGMP QC instrumentation including drafting Non-Conformance (NC) investigations

• Work closely with QC analysts, scientists, and supervisors to translate complex technical processes into clear, user-friendly documentation.

• Ensure all QC documentation meets Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and other applicable regulatory requirements.

• Support technology transfer, method qualification/validation, and implementation of new instruments or systems by preparing appropriate documentation.

• Draft, edit, and maintain QC-related standard operating procedures (SOPs), test methods, work instructions, protocols and reports.

• Standardize document templates and promote best practices in scientific and technical writing.

Work Location:

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

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly de