Data Audit Consultant

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.

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, 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.
• Able to reliably commute/work onsite in Bedford, NH 5 days per week.

Nice to Have Skills Experience

• 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.