System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems

System Level Review (SLR) & Audit Trail Review (ATR) Consultant - GxP Laboratory Systems

Location: Collegeville, PA (100% Onsite)

Pay: $70-85/hour W2 (depending on experience)

Benefits: Medical, Dental, Vision, 401(k), PTO, Paid Holidays, and more.

Alphanumeric is seeking an experienced System Level Review (SLR) & Audit Trail Review (ATR) Consultant to support a leading global pharmaceutical organization at its Collegeville, PA campus.

This role is ideal for a Computerized System Validation (CSV) professional with hands-on experience supporting laboratory equipment and computerized systems in a regulated GxP environment. The successful candidate will perform System Level Reviews, Audit Trail Reviews, and Data Integrity assessments while ensuring laboratory systems remain compliant, inspection-ready, and aligned with FDA regulatory expectations.

Candidates with experience performing Periodic Reviews, Computerized System Reviews, or equivalent laboratory system compliance assessments are encouraged to apply.

What you''ll be doing

• Perform System Level Reviews (SLRs) for laboratory equipment and computerized systems.
• Execute Audit Trail Reviews (ATRs) to evaluate system compliance, electronic records, and data integrity.
• Assess laboratory systems for compliance with GxP, FDA 21 CFR Part 11, and applicable regulatory requirements.
• Review audit trails, electronic records, user access, security controls, system configurations, and lifecycle documentation.
• Identify data integrity risks, compliance gaps, and opportunities for remediation.
• Author and review validation documentation, including risk assessments, validation plans, protocols, reports, periodic reviews, and change controls.
• Support Computerized System Validation (CSV) activities throughout the system lifecycle.
• Partner with Quality Assurance, Validation, Laboratory Operations, Engineering, and IT teams to ensure systems remain in a validated state.
• Support internal audits, regulatory inspections, and inspection readiness initiatives.
• Ensure validation deliverables meet established quality standards and project timelines.