Senior Analyst, Quality Control

Senior Quality Control Analyst

We are seeking a motivated Senior Quality Control (QC) Analyst to join our dynamic QC analytical team. This individual will closely collaborate with QC Management and technical specialists to support the culture and operations of an early-phase QC group. The position offers an exciting opportunity to learn and contribute in a startup environment based in Louisville, CO.

Responsibilities

• Demonstrate values as part of a high-performing, inclusive, and collaborative organization.
• Perform QC Analytical laboratory testing and review for product release, stability, and in-process testing under management supervision.
• Execute sample management tasks such as sample receipt, aliquoting, and managing the sample chain of custody.
• Collaborate with the Analytical Development team to perform testing in support of method qualification and transfer and provide QC perspective for method troubleshooting.
• Participate in Operational Excellence/Continuous Improvement activities in a regulated laboratory environment.
• Independently manage daily laboratory tasks such as inventory management, critical reagent qualification, and cell passaging.
• Support QC Operations, including QC Microbiology tasks, stability timepoint pulls, and other duties as needed.

Essential Skills

• Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life sciences.
• 1+ year of experience in a cGMP regulated QC environment for Analyst Level; 2+ years for Senior Analyst Level.
• Quality Control experience in a cGMP regulated laboratory.
• Molecular biology background, including dPCR, ELISA, Flow Cytometry, and Cell-based assays.
• Ability to execute tasks based on approved documents with knowledge of pharmaceutical regulations and guidance.
• Strong teamwork skills and commitment to workplace culture.
• Ability to excel through collaboration and knowledge sharing.

Additional Skills & Qualifications

• Experience with laboratory startup, quality systems, and analytical methods.
• Laboratory experience with molecular assays like digital PCR, Flow Cytometry, ELISA, and/or cell-based test methods.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
• QC Microbiology experience and aseptic technique is a plus.
• Ability to gown aseptically and work in a Clean Room environment.
• Capability to wear personal protective equipment and work in lab environments.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $26.98 - $40.38/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)

Workplace Type

This is a fully onsite position in Louisville, CO.

Application Deadline

This position is anticipated to close on Oct 27, 2025.