Katalyst CRO ยท 1 month ago
Data Integrity SME (Quality Assurance)
San Francisco, CA
Contract
Onsite
Senior Level, Lead/Staff
10+ years expKatalyst CRO is seeking a highly skilled Data Integrity SME with a strong Quality Assurance background. The ideal candidate will ensure data integrity compliance across analytical systems and support ongoing QA activities related to laboratory instrumentation.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Serve as the Subject Matter Expert (SME) for Data Integrity across analytical laboratory systems
Review, assess, and verify the data ranges, electronic records, and audit trail functionality of analytical instruments
Lead data integrity gap assessments and remediation activities for QC analytical equipment
Ensure compliance with FDA, GMP, ALCOA+, and pharmaceutical industry standards
Collaborate with QC, QA, and IT teams to ensure proper documentation, system configuration, and control of analytical lab equipment
Review and author technical documentation, including SOPs, validation reports, protocols, and equipment lifecycle documents
Support investigations, CAPAs, and change controls related to analytical systems
Provide QA oversight for analytical instrument qualification, calibration, and system updates
Train laboratory users on data integrity requirements and best practices
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline
510+ years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment
Strong hands-on background with analytical laboratory equipment (HPLC, UPLC, GC, UV, IR, Dissolution, etc.)
Proven expertise in Data Integrity principles, protocols, assessments, and remediation
Experience reviewing analytical instrument data, metadata, audit trails, and system configurations
Strong understanding of 21 CFR Part 11, Annex 11, ALCOA+ principles, and GxP documentation practices
Excellent communication and documentation skills
Ability to start within 2 weeks of offer
Experience in QC/QA oversight of computerized systems
Background in laboratory informatics systems (e.g., Empower, LabSolutions, Chromeleon, LIMS)
Prior experience working in top-tier pharmaceutical environments
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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