Quality assurance engineer Jobs in Boulder, CO

The Quality Assurance Specialist will support a state-of-the-art lentiviral vector development and manufacturing facility by overseeing quality documentation for externally manufactured products, managing incoming GMP material release and disposition, and contributing to broader QA activities. This role partners closely with Supply Chain, Manufacturing, and external vendors to ensure product quality, regulatory compliance, and continuous improvement in a dynamic cell and gene therapy environment.

• Perform detailed quality review of executed batch records, manufacturing records, and associated release documentation received from Contract Manufacturing Organizations (CMOs).
• Review manufacturing deviations, investigations, change controls, corrective and preventive actions (CAPAs), and other quality events that impact external batch disposition.
• Evaluate manufacturing and testing documentation to support final external batch release disposition decisions in alignment with cGMP and regulatory expectations.
• Perform quality review and disposition of incoming GMP materials used in the GMP manufacturing facility, ensuring materials meet specifications and are appropriately controlled.
• Support the Vendor Management program by participating in vendor oversight activities and helping ensure vendors meet quality and regulatory requirements, as needed.
• Author, review, and approve Standard Operating Procedures (SOPs) and other controlled documents as a Quality Assurance representative, ensuring documentation is accurate, compliant, and current.
• Collaborate cross-functionally with QA Operations, Supply Chain, Manufacturing, and vendors to resolve issues, support continuous improvement, and maintain alignment on quality standards.
• Work with materials management documentation, including revisions related to out-of-specification (OOS) results, deviations, batch record review, and updates within the ERP system (NetSuite).
• Participate in or support PQ (Performance Qualification) testing and related quality activities, as applicable.
• Communicate effectively with vendors and suppliers, as needed, to clarify quality requirements, address documentation questions, and support timely batch disposition.
• Contribute to the implementation and maintenance of quality management system elements, including risk management practices that support Phase 1 and first-in-human programs.
• Demonstrate a continuous improvement mindset by identifying opportunities to streamline processes, enhance compliance, and improve documentation quality.
• Perform other quality-related duties as assigned to support evolving business and operational needs.

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another life science discipline.
• Minimum of 5 years of work experience in an FDA-regulated industry, or a similar combination of education and experience.
• Demonstrated understanding of quality management systems and relevant pharmaceutical regulations and regulatory guidance.
• Experience supporting a cGMP biopharmaceutical manufacturing facility within a Quality organization.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and their application to manufacturing and testing operations.
• Hands-on experience with material release, material disposition, and material management in a GMP environment.
• Proficiency in quality review of batch records, manufacturing records, and associated release documentation.
• Experience reviewing and managing deviations, investigations, change controls, CAPAs, and other quality events.
• Familiarity with handling out-of-specification (OOS) investigations and related documentation.
• Experience working with ERP systems, preferably NetSuite ERP, in support of materials management and quality processes.
• Understanding of risk management principles and their application within a quality system, particularly for Phase 1 and first-in-human products and programs.
• Strong communication skills, with the ability to convey complex quality and compliance concepts clearly to cross-functional partners and vendors.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.
• Demonstrated ability to work effectively and efficiently in a collaborative manner across multiple functional areas and external partners.
• Commitment to collaborative values, accountability, continuous improvement, and solution-oriented thinking.

• Previous experience with a vendor management program in a cGMP environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facilities.
• Experience with PQ (Performance Qualification) testing in a GMP setting.
• Familiarity with FDA expectations for advanced therapy and biologics manufacturing.
• Comfort working in an emerging, innovation-driven biotech environment focused on novel immunotherapy platforms.
• Ability to bring new ideas, support lean and continuous improvement initiatives, and contribute to a culture of innovation.
• Proactive, communicative, and solution-oriented approach, with a focus on being accountable yet kind and collaborative.
• Ability to gown aseptically and work in a cleanroom environment, if required.
• Ability to work while gowned for extended periods of time, if required.
• Ability to stand for extended periods of time to fulfill on-the-floor quality duties, if required.
• Ability to work around laboratories, manufacturing areas, and equipment, including regular lifting of 10–20 lbs and occasional lifting of up to 50 lbs.
• Ability to work occasional nights and weekends as needed to support operational demands.
• Ability to primarily work onsite, with flexibility to work remotely when appropriate.

The role is primarily onsite at a state-of-the-art lentiviral vector development and manufacturing facility that supports cell and gene therapy manufacturing. The standard schedule is Monday through Friday, approximately 8:00 . to 5:00 ., with general flexibility to support caretaking responsibilities such as childcare or school drop-off. Occasional night and weekend work may be required based on operational needs. The position operates in a collaborative, shared-resource model with QA Operations, Supply Chain, and Manufacturing, often described as a 'One QC' approach, emphasizing teamwork and cross-functional support. The environment includes laboratories, manufacturing suites, and cleanroom areas, where aseptic gowning and working while gowned for extended periods may be required. The role involves regular movement around labs and production areas, use of laboratory equipment, and handling of chemicals and biological materials. Team members may need to regularly lift 10–20 lbs and periodically up to 50 lbs. The culture emphasizes diversity, equity, inclusion, continuous improvement, innovation, and a strong sense of purpose in developing transformative cancer therapies, with a focus on collaborative, communicative, and solution-oriented work.

This is a Contract position based out of Louisville, CO.

The pay range for this position is $40.97 - $50.63/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Louisville,CO.

This position is anticipated to close on Aug 6, 2026.