Quality Assurance Specialist

7 days ago


Arthur, Illinois, United States Lynkx Staffing LLC Full time
About the Role

This position plays a critical role in ensuring the quality and integrity of computerized systems within Lynkx Staffing LLC. As a Quality Assurance Specialist - Computer Systems, you will be responsible for reviewing and approving system validation and infrastructure qualification documentation, protocols, and reports, ensuring they meet regulatory requirements.

Responsibilities:
  • Documentation Review: Review and approve system validation and infrastructure qualification documentation, including Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols, and reports.
  • Collaboration: Work closely with IT and system owners to implement new computerized systems, upgrades, or modifications, ensuring compliance with regulatory requirements.
  • Leadership: Participate in project teams, providing guidance and support to ensure successful implementation and validation of computerized systems.
Requirements:
  • Bachelor's Degree: Scientific or Engineering discipline
  • Experience: 8+ years of computerized system experience with IT compliance/validation/qualification activities; 8+ years in an FDA-regulated, GxP-related environment
  • Skills: Comprehensive knowledge in Software Validation and Data Integrity Principles, experience with LIMS system implementations, and demonstrated expertise in 21 CFR Part 11
Estimated Salary: $115,000 - $145,000 per annum

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