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Job overview
Insight Global is hiring a Data Audit Consultant. The Data Audit Consultant will support a 6-month data-integrity initiative for a leading Contract Development and Manufacturing Organization (CDMO). This role focuses on evaluating audit trails, assessing system adequacy, and ensuring GMP-compliant data governance across manufacturing and quality systems. The consultant will review electronic records, verify the presence and completeness of audit trails, and ensure that data outputs meet regulatory expectations.
Key focus areas include Evaluate audit trails, Assess system adequacy, and Ensure GMP-compliant data governance across manufacturing and quality systems.
Successful candidates bring Bachelor's In Scientific/Engineering/Technical, 5+ Years GMP Experience, and Experience Sterile Manufacturing. Important skills include Audit Trail Review, Data Integrity Principles, GMP Manufacturing Systems, Electronic Record Compliance, MES, and SCADA. Preferred (not required): Sterile Fill-Finish.
Skills & qualifications
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Full job description
Job Description
The Data Audit Consultant will support a 6‑month data‑integrity initiative for a leading Contract Development and Manufacturing Organization (CDMO) specializing in sterile fill‑finish, lyophilization, and complex biologic and small‑molecule formulations. This role focuses on evaluating audit trails, assessing system adequacy, and ensuring GMP‑compliant data governance across manufacturing and quality systems. The consultant will review electronic records, verify the presence and completeness of audit trails, and ensure that data outputs meet regulatory expectations.
This position requires strong expertise in audit trail review, data integrity principles, and GMP manufacturing systems, with a particular emphasis on manufacturing equipment rather than analytical instrumentation.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
- Bachelor’s degree in a scientific, engineering, or technical field.
• 5+ years of GMP experience in pharma/biotech, ideally within sterile manufacturing or CDMO operations.
• Demonstrated expertise in audit trail review, data integrity, and electronic record compliance.
• Strong understanding of what an audit trail is, how it functions, and how to evaluate its adequacy.
• Experience reviewing audit trails for manufacturing equipment (MES, SCADA, PLC‑based systems, QMS platforms).
• Familiarity with MasterControl or similar electronic quality systems.
• Strong knowledge of 21 CFR Part 11, Annex 11, and global data‑integrity expectations.
• Excellent documentation, communication, and cross‑functional collaboration skills. • Experience in sterile fill‑finish, aseptic processing, or lyophilization environments.
• Prior CDMO experience supporting multi‑client, multi‑product operations.
Background in CSV/CSA, automation, or digital quality systems.
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