Data Integrity Specialist

United Pharma; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

United Pharma in Titusville, NJ seeks a Data Integrity Specialist to strengthen site-level data integrity and compliance by partnering with stakeholders, SMEs, and vendors within a regulated GMP environment. You will lead DI risk assessments, develop flow maps for lab equipment, support inspection readiness, and contribute to global DI initiatives through cross-functional collaboration.

This role requires strong technical writing, GDP knowledge, 21 CFR Part 11 expertise, and a related bachelor’s

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.
• 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.

Responsibilities

• 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.

Skills

Data integrity

Documentation practices

GxP knowledge

Risk assessment

Technical writing

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline

Tools

CSV validation

Regulatory software

Job description

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.