SPECTRAFORCE · 1 day ago
Lab Data Specialist
Cincinnati, OH
Contract
Onsite
Senior Level
$33/hr - $35/hr
6+ years expSPECTRAFOR is seeking a Data Integrity Specialist focused on QC Lab Data Review & Compliance. The primary responsibility is to clear a backlog of GMP data review and ensure compliance with documentation standards in a QC laboratory setting.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Keshav Bharti
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)
Qualification
Required
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
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 instrumentation, test methods, and product testing in pharma
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
H1B Sponsorship
SPECTRAFORCE 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 (3)
2024 (6)
2023 (1)
2022 (6)
2021 (8)
2020 (7)
Funding
Current Stage
Late StageCompany data provided by crunchbase