Kelly · 1 day ago
Senior Quality Assurance Specialist
Denver Metropolitan Area
Contract
Onsite
Senior Level, Lead/Staff
$52/hr - $64/hr
8+ years expKelly Science & Clinical is seeking a Quality Assurance Senior Specialist for a 6-month contract opportunity with a leading cell therapy biotechnology. The role involves safeguarding product quality and regulatory compliance by leading investigations into manufacturing quality events and driving continuous improvement initiatives to enhance GMP efficiency.
OutsourcingProfessional Services
Hiring Manager
Alexandre Neves, Ph.D.
Responsibilities
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—all in alignment with the event classification and regulatory expectations
Documentation Excellence: Ensure that all investigation records are accurate, compliant, and professionally structured—delivering clear, concise, and comprehensive reports on schedule to meet procedural and regulatory standards
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 Leadership: 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
Qualification
Required
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
Company
Kelly
We’ve been helping organizations find the people they need longer than any other company in the world.
10001+ employees
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
Recent News
Kelly Services, Inc.
2025-11-08
2025-11-08
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