Data Integrity Specialist

Data Integrity Specialist to support a leading pharmaceutical organization located in Titusville, NJ. The Data Integrity Specialist will strengthen site-level data integrity and compliance programs through partnering directly with site stakeholders, SMEs, and vendors to develop frameworks, conduct risk assessments, and support inspection readiness activities within a regulated GMP environment.

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.