Data integrity Specialist

Overview

On Site
Full Time

Skills

Data Integrity
HPLC
Root Cause Analysis
Corrective And Preventive Action
Testing
IP
Intellectual Property
Regulatory Compliance
GLP
GMP
Documentation
Auditing
Backup
Titration

Job Details

Job Description:
  • Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11).
  • Review audit trails, monitor user access, and perform periodic data reviews.
  • Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation.
  • Perform titration-based content uniformity tests as 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 and audit trails.
Responsibilities:
Data Integrity Compliance:
  • Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon, etc.).
  • 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.
OOS Investigation:
  • Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II).
  • Conduct root cause analysis, hypothesis testing, and propose CAPAs.
  • Document investigation narratives and track CAPA effectiveness.
Testing & Analysis:
  • Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP).
  • Calculate active ingredient content and assess batch uniformity.
Documentation & Compliance:
  • 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.
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