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Specialist Quality Control

Thousand Oaks, CA

Location: Onsite - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $39/$50 per hour (based on experience)

Summary of the Role

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.

Key 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

Required Experience & Skills

  • 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

Top 3 Must Have Skills

1. GxP laboratory systems and computer systems validation (IQ, OQ, PQ, UAT, data migration for ELN/LIMS/LMES; GAMP; 21 CFR Part 11)

2. Electronic laboratory workflow configuration, validation, and deployment; electronic procedures/templates; global QC support in biopharma

3. Quality systems expertise: SOP development, deviation/change control, CAPA, audit readiness, inspection defense

Day-to-Day Responsibilities

  • 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

Basic Qualifications

  • 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

This posting is for Contingent Worker, not an FTE

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