Quality Control Supervisor

University of Colorado•Aurora, CO

6d•Onsite

About The Position

This position is a full-time, supervisor-level position for the Quality Control (QC) team at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus. The QC supervisor ensures timely, compliant analytical support for GMP-regulated clinical manufacturing activities and maintains a high-performing QC team within a fast-paced, regulated environment. The QC Supervisor will supervise up to four direct reports, and is expected to have regular one-on-one meetings and supporting employee development. The QC Supervisor will be responsible for coordinating testing schedules, lead analytical troubleshooting, and support method development and qualification activities. This position requires strong technical expertise in analytical methods used for Cell Therapy and Biologics manufacturing, a solid understanding of experimental design, and will be performing analytical test methods as needed. Preferred areas of expertise include Environmental Monitoring, Microbiological methods, Flow Cytometry, HPLC, or other analytical platforms supporting Cell Therapy and Biologics manufacturing. This position will have a solid understanding of Quality principles such as Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Code of Federal Regulation (CFR), and United States Pharmacopeia (USP). All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory or cleanroom environment. This position will NOT support any academic research.

Requirements

Bachelor’s degree or equivalent experience in a related life science discipline or other relevant degrees.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
6+ years of Quality Control experience in a cGMP/GLP laboratory setting across multiple analytical disciplines
Demonstrated technical Subject Matter Expertise (SME) in at least one major Quality Control discipline such as Environmental Monitoring, Flow Cytometry, Chromatography (HPLC/UPLC), Molecular Biology (qPCR), Microbiology, or related analytical testing.
Applicants must meet minimum qualifications at the time of hire.

Nice To Haves

A master’s degree in scientific discipline, Biological Sciences, or a related field
10+ years of Quality Control experience in a cGMP/GLP laboratory setting across multiple analytical disciplines
1+ years of experience in personnel management
Demonstrated progression into leadership roles supporting QC operations, investigations, and cross-functional GMP decision making
Experience with analytical method development, qualification, or verification
Experience with 21 CFR 58, 210, 211, 600, 1271, and 11
Experience with experimental design and analytical troubleshooting
Experience with QC/QA principals and quality systems
Experience designing and implementing systems within a GMP environment

Responsibilities

Perform analytical testing in support of in-process, release, stability, environmental monitoring, and investigational testing programs, as needed.
Execute analytical methods in accordance with approved procedures, protocols, and GMP requirements.
Perform data analysis and documentation associated with analytical testing activities.
Perform preventative maintenance and routine troubleshooting of analytical equipment, as needed.
Serve as a technical resource during execution of complex or high-priority testing activities.
Oversee daily execution, coordination, and operational performance of the QC laboratory.
Manage the QC testing schedule across in-process, release, stability, and environmental monitoring programs.
Assign assays and workload to QC staff, ensuring alignment with manufacturing timelines.
Monitor and report QC metrics including turnaround times, deviations, and laboratory capacity.
Foster a positive, collaborative, and compliance-focused laboratory culture.
Lead troubleshooting of analytical methods and laboratory issues, including equipment, reagents, and assay performance.
Serve as the primary technical resource for assigned analytical disciplines and provide troubleshooting support for assay performance, instrumentation, and laboratory operations.
Support development, qualification, transfer, and implementation of QC analytical methods for new and existing programs.
Perform data review of analytical data generated by analysts, as needed.
Draft, review, and manage analytical deviations, excursions, OOS/OOT investigations, CAPAs, and change controls within an electronic Quality Management System.
Lead day-to-day execution of laboratory investigations, deviations, environmental monitoring excursions, and OOS investigations, escalating complex events to the QC Manager as appropriate.
Ensure compliance with applicable GMP, GDP, CFR, USP, and internal quality requirements.
Track recurring laboratory issues and support continuous improvement initiatives.
Draft, review, and optimize analytical policies, SOPs, protocols, and technical reports.
Support implementation of laboratory process improvements and operational efficiency initiatives.
Identify opportunities to improve laboratory systems, workflows, and analytical support activities.
Conduct routine one-on-one meetings, performance coaching, training oversight, and employee development activities for direct reports.
Train, mentor, and coach QC staff on analytical techniques, documentation expectations, and GMP compliance.
Support onboarding, training effectiveness monitoring, and competency development activities.
Promote accountability, teamwork, and professional growth within the QC organization.