System Level Review (SLR) & Audit Trail Review (ATR) Consultant – GxP Laboratory Systems
$145,600–$176,800 year
On-siteCollegeville, Pennsylvania, United States
Job Summary
Perform System Level Reviews (SLRs) and Audit Trail Reviews (ATR) for laboratory equipment and computerized systems to evaluate compliance with GxP, FDA 21 CFR Part 11, and data integrity standards. Assess system configurations, user access, security controls, and lifecycle documentation while identifying risks and remediation opportunities. Author validation documentation including risk assessments, protocols, and change controls, partnering with Quality Assurance, Validation, Engineering, and IT teams to maintain a validated state. Support internal audits and inspection readiness initiatives, ensuring deliverables meet quality standards and project timelines.
Required Qualifications
- 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
- Strong knowledge of FDA 21 CFR Part 11
- Strong knowledge of Data Integrity (ALCOA+)
- Strong knowledge of Electronic Records and Electronic Signatures
- Strong knowledge of Change Control and Risk Assessment
- Experience supporting laboratory computerized systems and laboratory equipment
- Strong technical writing, documentation, and communication skills
- 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
Desired Qualifications
- Experience with Waters Empower
- Experience with LabWare LIMS
- Experience with LabVantage
- Experience with Chromeleon
- Experience with OpenLab
- Experience with Electronic Laboratory Notebooks (ELN)
- Experience with Veeva
- Experience with Kneat
- Experience with ValGenesis
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