Data Integrity Specialist — GMP Lab Compliance & Risk

Piper Companies; Titusville (NJ); On-site; USD 76,000 - 103,000; Full time

Benefits offered by this job

Medical benefits

Dental & vision insurance

Retirement plans

15 month contract

Job summary

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in Titusville, NJ. The role focuses on building data integrity frameworks, enabling stakeholder collaboration, and ensuring GMP/GxP compliance across a laboratory environment.

Responsibilities include risk assessments, process mapping, and inspection readiness activities, with a strong emphasis on 21 CFR Part 11, Annex 11, and GDP practices.

Qualifications

• Experience supporting Data Integrity programs within GMP-regulated environments.
• Background in CSV and familiarity with laboratory computerized systems.

Responsibilities

• Develop and execute DI risk assessments for lab systems and processes.
• Create Level 3 process maps and run sessions with SMEs, vendors, and site stakeholders.
• Review risk assessments, audit trails, and quality records for gaps and improvements.
• Support configuration management for lab equipment and computerized systems.
• Collaborate to implement DI methodologies and assist in training.

Skills

DI programs experience

CSV background

21 CFR Part 11 knowledge

Annex 11 familiarity

GDP awareness

GxP compliance

Audit trails review

Tools

Computerized systems

Job description

Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in Titusville, NJ. The role focuses on building data integrity frameworks, enabling stakeholder collaboration, and ensuring GMP/GxP compliance across a laboratory environment.

Responsibilities include risk assessments, process mapping, and inspection readiness activities, with a strong emphasis on 21 CFR Part 11, Annex 11, and GDP practices.