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Ecocareers · 1 week ago

Data integrity Specialist

Edison, NJ

Full-time

Onsite

Mid Level

Ecocareers is a company focused on maintaining data integrity in laboratory environments. The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems, ensuring compliance with regulatory standards and good documentation practices.

Staffing & Recruiting

Responsibilities

Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon)

Ensure adherence to ALCOA+ principles and regulatory requirements (21 CFR Part 11, Annex 11)

Review audit trails, monitor user access, and perform periodic data reviews

Maintain accurate documentation of chromatograms, integration parameters, and calculations

Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II)

Conduct root cause analysis, hypothesis testing, and propose CAPAs

Document OOS investigation narratives and track CAPA effectiveness

Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP)

Calculate active ingredient content and assess batch uniformity

Ensure compliance with GLP, GMP, and good documentation practices

Maintain validated systems with secure electronic records, audit trails, and backup protocols

Review and approve titration method logs, normality calculations, and endpoint determinations

Qualification

HPLC systemsData integrity complianceAudit trail reviewGLP/GMP experienceOOS investigationsTitration testingRoot cause analysisCAPA implementationDocumentation practices