Specialist Quality Control
Advanced Bio-Logic Solutions Corp•Thousand Oaks, CA
•Onsite
About The Position
Serve as a System Administrator supporting business processing environments for a big biopharma leader. Oversee installation, configuration, and maintenance of operating systems, servers, and layered products while ensuring compliance. Troubleshoot technical issues, schedule system upgrades, and play a key role in the validation and deployment of GxP laboratory systems in regulated environments.
Requirements
- Extensive experience with GxP laboratory systems and computer systems validation, including hands-on IQ, OQ, PQ, UAT, and data migration verification for ELN, LIMS, and LMES platforms aligned with GAMP and 21 CFR Part 11 requirements
- Proven background in electronic laboratory workflow design, configuration, validation, and deployment for global QC operations in regulated biopharmaceutical environments
- Strong expertise in quality systems within biopharmaceutical QC environments, including SOP development, deviation and change control management, CAPA support, audit readiness, and inspection defense
- GxP laboratory systems and computer systems validation (IQ, OQ, PQ, UAT, data migration for ELN/LIMS/LMES; GAMP; 21 CFR Part 11)
- Electronic laboratory workflow configuration, validation, and deployment; electronic procedures/templates; global QC support in biopharma
- Quality systems expertise: SOP development, deviation/change control, CAPA, audit readiness, inspection defense
- Doctorate degree
- Masters degree and 2 years of experience
- Bachelors degree and 4 years of experience
- Associates degree and 8 years of experience
- High school diploma / GED and 10 years of experience
Responsibilities
- Install, configure, and maintain operating systems, servers, and ancillary products with compliance to licensing and maintenance agreements
- Troubleshoot, respond to escalations, and perform hardware or software repairs as needed
- Schedule and oversee hardware and software installations and upgrades
- Participate in process engineering activities and facilitate new business SOPs, forms, and manuals for evolving electronic workflows
- Participate in system requirement gathering, configuration, and design activities for the new ELN system
- Verify and manage site master data
- Coordinate ELN Template development and review with site subject matter experts
- Support development and review of Operational Qualifications (OQ), User Acceptance Testing (UAT), and Data Migration Verification
- Contribute to the review and input of training materials, and support instrument qualification activities at the site
- Install and upgrade software and hardware components per schedule
- Troubleshoot escalated technical issues and execute repairs
- Lead ELN system process engineering and facilitate new business documentation
- Participate in requirements gathering, system design, and configuration
- Coordinate with site SMEs for ELN Template development and review
- Execute and verify UAT and data migration efforts
- Review, develop, and support training materials
- Assist in planning and executing site instrument qualifications
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What This Job Offers
Career Level
Mid Level
Education Level
High school or GED
