Katalyst CRO · 1 week ago
Senior Quality Assurance Specialist
Louisville, CO
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is a company seeking a Senior Quality Assurance Specialist to lead deviation investigations and ensure compliance with quality event documentation. The role involves managing change control records and continuous improvement initiatives while effectively communicating project statuses across teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Own end-to-end deviation investigations and effectively collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification
Ensure clarity, accuracy, and compliance of quality event documentation that meets procedural, regulatory, and phase-appropriate expectations
Deliver high-quality deviation investigation reports that are complete, concise, clear, and submitted within defined timelines
Own change control records and manage effective execution and closure by drafting organized, well-structured change action plans and driving implementation
Manage continuous improvement initiatives from concept through execution by tracking progress with owners and stakeholders
Communicate status of investigations, quality event records (Deviations, Change Controls, CAPAs) and Continuous Improvement projects at cross-functional and manufacturing-specific group meetings
Qualification
Required
Bachelors in Biochemistry, Cell & Molecular Biology or related Life Science discipline
Minimum of 8 years of experience with deviation investigation and complex root cause investigational tools (e.g., fishbone, 6M)
Ability to gown aseptically and work in a Clean Room environment and Ability to work while gowned for extended periods of time, including standing for extended periods of time
Demonstrated ability to use risk-based decision-making in support of deviation investigation and quality event reporting
Excellent written and verbal communication skills, with the proven ability to deliver clear, concise reports in a GMP manufacturing environment
Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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