Seeking a Quality Assurance Specialist to support GMP operations at a state-of-the-art biopharma manufacturing facility in Louisville, CO. The role involves providing quality oversight of incoming materials, manufacturing, and GMP documentation, ensuring compliance with regulations and standards. Key responsibilities include reviewing and approving SOPs, batch records, QC documentation, initiating quality holds, and supporting continuous improvement efforts. Requires a Bachelor's degree in a life science field with at least 5 years of experience in an FDA-regulated industry and knowledge of GMP systems. Preferred experience includes cell and gene therapy manufacturing. This onsite position offers a salary range of $85,300 - $105,300, with comprehensive benefits such as health plans, 401k with match, PTO, and more. Physical requirements include working on-site, lifting up to 20 lbs, and supporting off-hours work when needed.