What are the responsibilities and job description for the GxP Compliance Systems Specialist position at Alliance Biotech Solutions?
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.
Required Qualifications
- Experience in a GxP facility support and ability to work independently and collaboratively as part of a team.
- Ability to be persistent with assignments and take initiative to ensure deadlines are met.
- Experience in a life science laboratory environment with knowledge of laboratory equipment and software.
- Ability to work onsite in Thousand Oaks, CA
- Strong proficiency in Microsoft Word and Excel.
- Understanding of computer system validation.
- Understanding of data integrity standards and 21 CFR Part 11.
- Good project management skills.
- Excellent communication and interpersonal abilities.
Preferred Qualifications
- Experience supporting Lab systems including configuration and troubleshooting.
Additional Notes
- This role will provide weekend support in rotation with teammates and work off hours as necessary to support site production needs.
- A strong commitment to maintaining data integrity and compliance with industry regulations is essential for success in this role.