Data Integrity Consultant

Responsibilities

• Support retrospective Data Integrity reviews in a GMP QC laboratory following a recent Data Integrity assessment.
• Focus on reviewing historical laboratory data, investigating identified gaps, assessing potential product impact, and supporting remediation activities where required.
• Review historical laboratory records and data as part of retrospective Data Integrity assessments.
• Support review of unexplained trial injections, especially related to HPLC / chromatography data.
• Review GDP documentation issues and assess completeness, accuracy, and compliance of laboratory records.
• Support retrospective review of OOS investigations to confirm appropriate investigation, root cause, impact assessment, and closure.
• Review data and documentation related to standalone laboratory instruments.
• Assess whether identified Data Integrity gaps may have impacted released products.
• Document findings clearly and support preparation of investigation summaries, impact assessments, and remediation actions.
• Support CAPA definition and remediation planning, if required.
• Work onsite with Quality, QC, Manufacturing, and site SMEs.

Qualifications

• Strong experience in GMP QC laboratory environments.
• 3 - 4+ years of experience.
• Hands-on experience with Data Integrity, ALCOA+ / ALCOA++, and laboratory documentation review.
• Experience with retrospective data review and product impact assessments.
• Good understanding of HPLC / chromatography systems and trial injections.
• Experience reviewing OOS investigations, GDP documentation, audit trails, and laboratory records.
• Ability to investigate gaps, identify root cause, and document findings clearly.
• Experience supporting remediation, CAPA, or inspection readiness activities.
• Strong understanding of GMP product manufacturing and laboratory processes.
• Preferred: Experience in sterile or aseptic manufacturing environments.
• Experience with FDA-regulated sites.
• Experience with standalone laboratory instruments and chromatographic data systems.
• Previous experience supporting Data Integrity remediation projects after internal or external assessments.