On-Site Data Integrity Specialist – GMP Compliance Lead

Piper Companies; Titusville (NJ); Sur place; USD 76 000 - 103 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

401(k)

PTO

Résumé du poste

Piper Companies seeks a Data Integrity Specialist for a leading pharmaceutical organization in Titusville, NJ. The role focuses on strengthening site-level data integrity and compliance programs in a GMP environment, partnering with stakeholders to develop frameworks and support inspection readiness.

Responsibilities include risk assessments, process mapping, and training development to ensure robust DI controls. On-site, contract length 15 months, with a comprehensive benefits package.

Qualifications

• Experience supporting Data Integrity initiatives within a GMP-regulated pharmaceutical environment.
• Background in Computer System Validation (CSV) and Data Integrity preferred.
• Working knowledge of 21 CFR Part 11 and Annex 11 regulatory requirements.
• Strong understanding of Good Documentation Practices (GDP); GDP experience is required.
• Experience conducting data reviews, compliance reviews, or internal audits.

Responsabilités

• Develop and execute Data Integrity risk assessments across laboratory equipment, systems, and processes.
• Create and maintain Level 3 process flow maps, focusing on laboratory balances and related equipment.
• Facilitate sessions with site stakeholders, equipment SMEs, and vendors to identify and mitigate DI risks.
• Review existing risk assessments, identify compliance gaps, and recommend improvements.
• Support compliance assessments, configuration management activities, and inspection readiness initiatives.

Connaissances

Data integrity

CSV knowledge

21 CFR Part 11

GDP knowledge

Regulatory compliance

Stakeholder management

Technical writing

Quality documentation

Cross-functional collaboration

Formation

Bachelor's degree in science or engineering

Outils

CSV Validation Tools

Electronic Document Management System

Description du poste

Piper Companies seeks a Data Integrity Specialist for a leading pharmaceutical organization in Titusville, NJ. The role focuses on strengthening site-level data integrity and compliance programs in a GMP environment, partnering with stakeholders to develop frameworks and support inspection readiness.

Responsibilities include risk assessments, process mapping, and training development to ensure robust DI controls. On-site, contract length 15 months, with a comprehensive benefits package.