GxP Compliance Systems Specialist

Job Description

Job Description

Description : About the job

ABS is seeking an enthusiastic candidate for an onsite position located in Thousand Oaks, California, to support our client in an exciting role. This position focuses on supporting the documentation and technical aspects of laboratory systems in a GMP environment.

Role Overview

This role will be responsible for ensuring the technical and regulatory compliance of laboratory systems (e.g., 21 CFR Parts 210, 211, EU Annex 11, GLP, GMP, ISO). The role involves close collaboration with laboratory personnel, Quality Assurance, Validation, and IT teams to support day to day operations, ensure data integrity, and maintain compliance in a life sciences drug manufacturing facility.

Key Responsibilities

• Conduct technical system reviews, including user audits, audit trails, and other system-related assessments.
• Perform periodic reviews to assess system operations for changes, deviations, and technical operations to ensure the system operates in a validated state.
• Support daily instrument operations, managing user issues and troubleshooting.
• Coordinate with vendors to manage instrument maintenance and updates.
• Maintain user access controls and permissions.
• Provide technical support and troubleshooting for laboratory instruments, PCs, servers, and related applications.
• Respond promptly to technical inquiries, resolving issues to minimize operational disruptions.
• Collaborate with vendors and stakeholders for application and firmware updates, offering technical expertise.
• Develop and maintain documentation for application support.

Additional Notes

Requirements :

Required Qualifications

Preferred Qualifications