| Location | Titusville, NJ |
| Salary | $55–$75 Per Hour |
Responsibilities: of the Data Integrity Specialist: • Develop and execute Data Integrity (DI) risk assessments across laboratory equipment, systems, and processes. • Create and maintain Level 3 process flow maps, with an initial focus on laboratory balances and related equipment. • Facilitate working 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. • Participate in global DI methodology discussions and help implement global requirements at the site level. • Develop, review, and maintain GxP summary documents, audit trail reviews, periodic reviews, and other DI-related documentation. • Support training and communication efforts across the organization, including development of DI training curricula. • Assist with delivery of Data Integrity training programs and workshops for end users and stakeholders. Qualifications: of the Data Integrity Specialist: • 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. • Proven ability to work directly with stakeholders, SMEs, and cross-functional teams to build compliance frameworks. • Strong technical writing and documentation skills. • Experience developing risk assessments, process maps, and controlled quality documentation. • QC Laboratory and/or Stability Laboratory experience is highly preferred. • Familiarity with laboratory or stability equipment is a strong plus. • Bachelor's degree in a scientific, engineering, quality, or related discipline preferred. Compensation: for the Data Integrity Specialist: • Salary range: $55/hr-75/hr • Comprehensive benefits package including medical, dental, vision, 401(k), and PTO • Job term: 15 months, fully on-site Application Period: This job opens for applications on 10/18/2026. Applications for this job will be accepted for at least 30 days from the posting date.