Data Audit Consultant

The Data Audit Consultant will support a 6month dataintegrity initiative for a leading Contract Development and Manufacturing Organization (CDMO) specializing in sterile fillfinish, lyophilization, and complex biologic and smallmolecule formulations. This role focuses on evaluating audit trails, assessing system adequacy, and ensuring GMPcompliant 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.

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Required Skills & Experience
• 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, PLCbased systems, QMS platforms).
• Familiarity with MasterControl or similar electronic quality systems.
• Strong knowledge of 21 CFR Part 11, Annex 11, and global dataintegrity expectations.
• Excellent documentation, communication, and crossfunctional collaboration skills.


Nice to Have Skills & Experience
• Experience in sterile fillfinish, aseptic processing, or lyophilization environments.
• Prior CDMO experience supporting multiclient, multiproduct operations.
Background in CSV/CSA, automation, or digital quality systems.


Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.