Data Integrity Specialist
Piper Companies · Titusville, NJ · 3 wk ago
On-siteInformation Technology$55–$75/hrFull-time
About the role
Piper Companies is seeking a Data Integrity Specialist to support a leading pharmaceutical organization in developing and implementing site‑level data integrity initiatives within a laboratory environment in Titusville, NJ.
Responsibilities
- Develop and execute Data Integrity (DI) risk assessments for laboratory systems, equipment, and processes.
- Create Level 3 process flow maps and facilitate working sessions with SMEs, vendors, and site stakeholders to identify and mitigate DI risks.
- Review existing risk assessments, compliance documentation, audit trails, periodic reviews, and other GxP‑related records to identify gaps and improvement opportunities.
- Support configuration management activities for laboratory equipment and computerized systems while assisting with inspection readiness initiatives.
- Collaborate with teams to implement DI methodologies, communicate requirements, and support training initiatives across the organization.
Qualifications
- Experience supporting Data Integrity programs within a GMP‑regulated pharmaceutical, biotechnology, or life sciences environment.
- Background in Computer System Validation (CSV) and familiarity with computerized systems used in laboratory settings.
- Working knowledge of 21 CFR Part 11, Annex 11, Good Documentation Practices (GDP), and GxP requirements.
- Experience reviewing technical documentation, audit trails, quality records, and compliance‑related documentation.
- QC Laboratory, Stability Laboratory, internal auditing, or laboratory equipment experience is strongly preferred.
Pay
Pay Range: $55‑$75 per hour (depending on experience). 15‑month contract position.
Benefits
Comprehensive benefits package including medical, dental, vision, and retirement plans.