Senior Quality Assurance Specialist

Base Pay Range

$52.00/hr - $64.00/hr

Direct message the job poster from Kelly

Kelly® Science & Clinical is seeking a Quality Assurance Senior Specialist for a 6-month contract opportunity with one of our clients, a leading cell therapy biotechnology at their Louisville, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Workplace: Onsite in Louisville, CO

Pay Rate: $52–64/hr, commensurate with experience

Schedule & Duration:

Monday–Friday, Day Shift | Approx. 6 months

Join a dynamic and mission-driven team at the forefront of cell therapy manufacturing. As the Quality Assurance Records Sr. Specialist, you will play a pivotal role in safeguarding product quality and regulatory compliance by leading comprehensive investigations into manufacturing quality events. You will champion the creation of well-documented deviation records, take full ownership of change control processes, and drive impactful continuous improvement initiatives to elevate GMP efficiency across our organization.

• Lead Deviation Investigations – Take ownership of end-to-end deviation investigations, collaborating cross-functionally to ensure all quality events are investigated thoroughly and with the appropriate level of rigor and documentation, delivering clear, concise, and comprehensive reports on schedule.
• Change Control Stewardship – Manage the lifecycle of change controls—from drafting well-defined action plans to overseeing execution, closure, and implementation—ensuring smart and seamless adoption of process improvements.
• Continuous Improvement Projects – Inspire and manage continuous improvement projects from conceptualization to execution, tracking milestones and collaborating proactively with process owners and key stakeholders to drive GMP efficiency.
• Effective Cross-Functional Communication – Serve as a communications lead for the status of deviation investigations, change controls, CAPAs, and process improvements, sharing updates during cross-functional and manufacturing-specific meetings.

• Bachelor’s degree in Biochemistry, Cell & Molecular Biology, or a related Life Science discipline.
• Minimum of 8 years’ experience leading deviation investigations and applying advanced root cause analysis tools (such as fishbone diagrams, 6M, etc.) within a GMP environment.
• Proven ability to gown aseptically and work for extended periods in a Clean Room environment, including standing for long durations.
• Strong risk-based decision-making skills supporting high-quality deviation investigations and quality event management.
• Exceptional written and verbal communication abilities, with demonstrated experience authoring clear, concise, and impactful reports in a regulated manufacturing setting.
• Advanced project management capabilities, with a track record of independently navigating and closing multiple quality events and projects simultaneously.

What happens next?

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.