Data integrity Specialist

Edison, NJ, US • Posted 30+ days ago • Updated 10 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

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

Summary

Job Summary:

The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards such as 21 CFR Part 11 and Annex 11.
The role ensures compliance with GLP, GMP, and good documentation practices while supporting validated systems, audit readiness, and laboratory data accuracy.

Roles & 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.

Education & Experience:

Experience working in GLP/GMP-regulated laboratory environments.
Hands-on experience with HPLC systems (Empower, Chromeleon).
Experience in data integrity compliance, audit trail review, and periodic data review.
Experience leading OOS investigations (Phase I & II) and CAPA implementation.
Experience performing titration-based content uniformity testing per pharmacopeial guidelines.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 8457e9bd866ffabab9309191e1e897a0
Posted 30+ days ago

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Data integrity Specialist

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Job Details

Skills

Summary

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