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Validation Analyst 2

PCI Pharma Services · Rockford, IL +1 more

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Role summary

Validation Analyst II manages intermediate customer validation projects with responsibility for protocol development, execution, and audit support. The role ensures compliance with regulatory requirements and coordinates approvals across internal teams and customers at a pharmaceutical services company.

What they're looking for

  • High school diploma or GED with 3-5 years related experience
  • College-level mathematical skills
  • Intermediate computer skills and knowledge of various programs
  • Professional proficiency in written and oral communication
  • Intermediate reasoning and problem-solving ability
  • Knowledge of cGMP, GCP, GAMP, 21 CFR, and Annex 11 requirements

What you'll be doing

  • Develop and execute validation protocols, statements, and master validation plans for customer projects
  • Ensure validation documentation completion, accuracy, and closure with internal and customer approvals
  • Prepare change control reports and validation history documentation for customer audits
  • Investigate validation deviations and document corrective actions in formal reports
  • Serve as primary customer contact for validation activities and manage project expectations
Compensation$22.15-$24.92 per hour plus annual performance bonus eligibility

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Date posted1 day ago
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