Specialist, Quality Control Analytical

POSITION SUMMARY

As a Specialist, Quality Control Analytical, you’ll be a key member of our QC Analytical laboratories—collaborating within QC to generate high-quality data that supports lot release testing, product stability, and sample management. You’ll help drive continuous improvement across QC programs and processes, with the opportunity to grow into ownership of assigned QC programs and shape the future of the Quality Control organization.

This position will be fully onsite based out of our Louisville, CO location.

CORE ACCOUNTABILITIES

Specific responsibilities include: 

• Model the Umoja values and help build a high-performing, people-first, inclusive, and highly collaborative team culture.
• Independently perform QC analytical testing to support product release, stability programs (including protocol/report generation), and sample management (including aliquoting, distribution, and storage).
• Maintain data integrity and Good Documentation Practices (GDP) by ensuring accurate, contemporaneous, and complete records in accordance with SOPs and cGMP requirements.
• Review analytical data and QC documentation (e.g., notebooks/worksheets, calculations, protocols, and reports) for accuracy, completeness, and compliance; provide timely feedback to support right-first-time execution.
• Serve as a subject matter expert for assigned QC methods and technologies, partnering on troubleshooting, investigations, and continuous improvement.
• Support the development, implementation, and continuous improvement of phase-appropriate, compliant QC programs, systems, and processes (e.g., method lifecycle, trending, OOS/OOT investigations, invalids, critical reagents, LIMS).
• Partner with Analytical Development to provide QC input and hands-on support for method development, qualification, transfer, troubleshooting, and remediation.
• Champion Operational Excellence/LEAN in the QC laboratories, driving continuous improvement across programs, processes, and systems; lead assigned LEAN projects from launch through closeout.

The successful candidate will have:

• Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or a related life science, with a minimum of 5+ years of experience in a cGMP-regulated QC environment (or an equivalent combination of education and experience).
• Quality Control experience in a cGMP-regulated laboratory, including knowledge of the analytical method lifecycle (qualification, validation, and transfer).
• Strong molecular biology analytical background, including dPCR/PCR, ELISA, flow cytometry, and/or cell-based assays.
• Knowledge of relevant pharmaceutical regulations and guidance (e.g., FDA, ICH, Eur. Ph.).
• Passion for teamwork and an unwavering commitment to purpose, team success, and building an outstanding workplace culture.
• Demonstrated ownership of project deliverables within a cross-functional team.
• Firm grasp of Operational Excellence/continuous improvement principles, with experience applying them in a regulated laboratory environment.
• Ability to independently assess risk, propose viable solutions, and clearly communicate impact in a dynamic start-up environment.
• Ability to lead peers by example and elevate team performance through collaboration, teamwork, and effective knowledge sharing.
• Proven ability to self-manage internal and cross-functional projects and drive completion to timelines.

Preferred Qualifications: 

• Experience in a laboratory start-up environment, quality systems, and the analytical method lifecycle.
• Experience with digital PCR and cell-based methods.
• Experience in a cGMP cell and gene therapy manufacturing and/or testing facility.

Physical Requirements:  

• Ability to work onsite 5 days per week at our Louisville, CO location.
• Ability to work evenings and/or weekends as needed.

• Ability to wear personal protective equipment, including gloves, protective clothing, and eye safety glasses.
• Ability to work around laboratories, manufacturing areas, and equipment, and regularly lift 10–20 lbs.

Salary Range: $79,000 - $97,500