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Position Title: Data Integrity Specialist (QC Lab Data Review & Compliance) Work Location: Cincinnati, OH 45209 Assignment Duration: 6 months (with strong possibility of extension based on performance and business needs) Work Arrangement: Fully Onsite Role 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