Asepsis, Chromatographic Systems, Chromatography, Consulting, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Data Quality, Documentation, Documentation Review, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), Injections, Laboratory, Manufacturing, Manufacturing/Industrial Processes, Product Reviews, Product Support, Quality Control, Root Cause Analysis
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Data Integrity Consultant.
Position Type:Required:- 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.
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.
Key Responsibilities:- 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.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Priyanshu at 201-478-6913 to learn more.
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Hired by Matrix
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