Data integrity Specialist

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

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

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

Summary

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.

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: d4699192754768ce013523ca2278e03f
Posted 30+ days ago

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