Quality Assurance Specialist
7 days ago
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.
- 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
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Quality Assurance Validation Manager
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Arthur, Illinois, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a highly skilled Quality Assurance Validation Manager to join our team. As a Senior Computerized Systems Validation Specialist, you will play a critical role in ensuring the compliance of computerized systems with regulatory requirements.Job ResponsibilitiesProvide QA oversight and assurance that all GxP computerized...
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Quality Assurance Director
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Senior Quality Assurance Microbiologist
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Manager of Quality Systems
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Pharmaceutical Quality Assurance Expert
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Compliance Specialist
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Arthur, Illinois, United States Lynkx Staffing LLC Full timeJob DescriptionLynkx Staffing LLC is seeking a highly motivated and experienced Quality Assurance Manager to join our team in Allendale, NJ.About the PositionThis is a dynamic role that requires a strong understanding of quality assurance principles and practices. The successful candidate will be responsible for managing the PPU support unit services of the...
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Arthur, Illinois, United States Lynkx Staffing LLC Full timeJob Description:">The incumbent will be responsible for supporting the development and implementation of computerized system validation strategies in accordance with FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10, and industry standards. The role also involves providing QA oversight of all GxP computerized system activities implementation...
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Kitchen Associate
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Senior Care Specialist
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Caregiver Specialist
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Senior Care Specialist
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