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

- **Company:** Alphanumeric Systems, Inc.
- **Location:** Oaks, PA, United States
- **Salary:** $145,600.0 - $176,800.0
- **Contract:** Permanent contract
- **Skills:** Microsoft Access, Audit Trail, System Configuration, Data Integrity, Electronic Signatures, Laboratory Information Management Systems, Chromeleon, System Testing, Computerised Systems, Information Technology, Veeva, GXP
- **Published:** August 8, 2026
- **Apply:** https://www.disabledperson.com/jobs/74116773-system-level-review-slr-audit-trail-review-atr-consultant-gxp-laboratory-systems

## About the Role

* Bachelor's degree in Engineering, Computer Science, Chemistry, Biology, Life Sciences, or a related technical discipline.
 * Minimum 5 years of experience supporting GxP-regulated pharmaceutical, biotechnology, or life sciences environments.
 * Hands-on experience performing Computerized System Validation (CSV).
 * Experience conducting System Level Reviews (SLRs), Periodic Reviews, and/or Audit Trail Reviews (ATRs) for laboratory equipment or computerized systems.

Strong knowledge of:

 * GxP
 * FDA 21 CFR Part 11
 * Data Integrity (ALCOA+)
 * Electronic Records and Electronic Signatures
 * Change Control and Risk Assessment
 * Experience supporting laboratory computerized systems and laboratory equipment.
 * Strong technical writing, documentation, and communication skills.

Preferred Experience

Experience with one or more of the following systems is highly desirable:

 * Waters Empower
 * LabWare LIMS
 * LabVantage
 * Chromeleon
 * OpenLab
 * Electronic Laboratory Notebooks (ELN)
 * Veeva
 * Kneat
 * ValGenesis

Preferred Skills

 * Computerized Systems Validation (CSV)
 * Audit Trail Reviews
 * System Level Reviews
 * Data Integrity
 * CAPA
 * Risk Assessment
 * Change Control
 * Root Cause Analysis
 * Inspection Readiness
 * GAMP 5
 * Laboratory Compliance

Why Join Us?

This is an opportunity to support highly visible compliance initiatives within a global pharmaceutical organization. You'll work alongside cross-functional Quality, Validation, Engineering, and Laboratory teams on projects that directly impact regulatory compliance, data integrity, and inspection readiness.

Please Note: This is a 100% onsite position located in Collegeville, PA. Candidates must be authorized to work in the United States on a W2 basis. We are unable to accept third-party candidates or provide sponsorship now or in the future.

## Description

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

Responsibilities

 * 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.


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