Data Integrity Specialist (QC Lab Data Review & ...

Position Title: Data Integrity Specialist (QC Lab Data Review & Compliance)Work Location: Cincinnati, OH 45209Assignment Duration: 6 months (with strong possibility of extension based on performance and business needs)Work Arrangement: Fully OnsiteRole Summary:This is a purely QC laboratory-focused role (no R&D involvement).The main priority is to help clear a significant backlog of GMP data review and documentation compliance. Most of the daily work involves hands-on review and approval of data generated in Empower (chromatography data system).The lab uses SmartLab for electronic lab operations, so experience with SmartLab is a strong plus and will make training much faster (typically 2-3 weeks ramp-up with on-the-job support).The role is strictly documentation and electronic review-based: No handling of physical samples, no direct work with instruments or calibration (separate calibration specialists handle that). About 80% of the time is spent in electronic systems like Empower, LIMS, and SmartLab/ELN, with ~20% reviewing paper-based lab notebooks.Expected daily output: Approximately 40 Empower data reviews per 8-hour day (varies with complexity).Team has 9 members (7 analysts + 2 experienced data reviewers), and you'll get good support from seniors with deep knowledge for quick learning.Top Key Requirements:6+ years of hands-on experience in a GMP-regulated lab environment (QC preferred, strong data integrity & compliance focus).Solid background in QC data review and GMP documentation compliance (backlog clearance type experience ideal).Hands-on experience reviewing and processing Empower-generated chromatography data - this is critical and the primary tool.Working knowledge of LIMS and Electronic Lab Notebooks (ELN); SmartLab experience highly preferred (big advantage for faster onboarding).Strong understanding of FDA regulations, especially 21 CFR Part 11, data integrity principles (ALCOA+), and pharma QC compliance standards.Main Responsibilities:Focus on clearing the QC data review backlog, primarily through detailed Empower data review and approval.Serve as QC lab compliance specialist: Perform routine assessments, report monthly compliance concerns to management, ensure completion of quarterly LIR/data review checklists, and coordinate any lab audits.Review and assess QC documents (methods, protocols, calibration records) for regulatory compliance, identify gaps, and implement improvements.Coordinate review of compendial changes (USP/EP) and assign necessary verification testing.Act as calibration documentation coordinator: Approve/schedule service requests, assess impact on qualification, review instrument investigations, and manage work orders in Maximo (documentation only, no hands-on).Collaborate on procurement, installation, calibration, and qualification of lab instruments (review/approval side).Participate in validation review board for equipment qualifications.Assist in quality system enhancements, procedure design, and occasionally support training material updates or delivery (materials already exist online).Qualifications: Required:Bachelor's degree in Chemistry, Biology, Pharmacy, Microbiology, Engineering, or related scientific field (Master's acceptable, not overqualified).4+ years in quality assurance/oversight or relevant QC lab experience (6+ GMP years strongly preferred).Proven GMP compliance mindset with excellent attention to detail and ability to handle high-volume data review independently.Strong oral/written communication and interpersonal skills for team collaboration.Preferred:Direct SmartLab experience (speeds up ramp-up significantly).Familiarity with Maximo or similar systems.Knowledge of common lab instrumenta

Created: 2026-01-16