Data Integrity Specialist | Edison, NJ (Onsite) | Contract

Overview

On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Analytical Skill
Auditing
Backup
Collaboration
Conflict Resolution
Corrective And Preventive Action
Data Integrity
Documentation
GDP
GLP
GMP
HPLC
IP
Intellectual Property
Life Sciences
Management
Pharmaceutics
Problem Solving
Quality Assurance
Quality Control
Regulatory Compliance
Root Cause Analysis
Testing
Titration

Job Details

Job Title: Data Integrity Specialist
Location: Edison, NJ (Onsite)
Employment Type: Contract

Job Summary

We are seeking a Data Integrity Specialist to implement and maintain data integrity controls for laboratory systems, primarily HPLC platforms (Empower, Chromeleon). The role focuses on ensuring compliance with ALCOA+ principles, 21 CFR Part 11, and EU Annex 11, while supporting OOS investigations, laboratory testing activities, and regulatory documentation in a GMP/GLP environment.

Key Responsibilities

< data-start="738" data-end="774">Data Integrity & Compliance</>

  • Implement and maintain data integrity controls for HPLC systems including Empower and Chromeleon.

  • Ensure compliance with ALCOA+ principles, 21 CFR Part 11, EU Annex 11, and internal quality standards.

  • Review and analyze audit trails, monitor user access, and perform periodic data integrity reviews.

  • Maintain accurate and complete documentation for chromatograms, integration parameters, calculations, and electronic records.

< data-start="1238" data-end="1265">OOS Investigations</>

  • Lead and support Out-of-Specification (OOS) investigations (Phase I and Phase II).

  • Perform root cause analysis, hypothesis testing, and recommend Corrective and Preventive Actions (CAPA).

  • Document investigation reports and track CAPA effectiveness to closure.

< data-start="1551" data-end="1589">Laboratory Testing & Analysis</>

  • Perform titration-based content uniformity testing in accordance with SOPs and pharmacopeial standards (USP, IP, BP).

  • Calculate active ingredient content and evaluate batch uniformity and compliance.

< data-start="1811" data-end="1851">Documentation & Quality Systems</>

  • Ensure adherence to GLP, GMP, and Good Documentation Practices (GDP).

  • Maintain validated laboratory systems with secure electronic records, audit trails, and backup procedures.

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

Required Skills & Experience

  • Hands-on experience with HPLC systems (Empower required; Chromeleon preferred).

  • Strong knowledge of Data Integrity, ALCOA+, 21 CFR Part 11, and Annex 11.

  • Experience leading or supporting OOS investigations and CAPA management.

  • Exposure to titration methods, content uniformity testing, and pharmacopeial guidelines.

  • Experience working in GMP / GLP-regulated environments.

Preferred Qualifications

  • Prior experience in pharmaceutical, biotech, or life sciences laboratories.

  • Strong documentation, analytical, and problem-solving skills.

  • Ability to work onsite and collaborate with cross-functional QC, QA, and validation teams.

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About Anagha Techno Soft