Specialist Quality Control

Location: Onsite - Thousand Oaks, CAEmployment Type: Contingent Worker (Contract, W2)Contract Length: 12 months (possible extension)Compensation: $39/$55 per hour (based on experience)Summary of the RoleServe 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 ResponsibilitiesInstall, configure, and maintain operating systems, servers, and ancillary products with compliance to licensing and maintenance agreementsTroubleshoot, respond to escalations, and perform hardware or software repairs as neededSchedule and oversee hardware and software installations and upgradesParticipate in process engineering activities and facilitate new business SOPs, forms, and manuals for evolving electronic workflowsParticipate in system requirement gathering, configuration, and design activities for the new ELN systemVerify and manage site master dataCoordinate ELN Template development and review with site subject matter expertsSupport development and review of Operational Qualifications (OQ), User Acceptance Testing (UAT), and Data Migration VerificationContribute to the review and input of training materials, and support instrument qualification activities at the siteRequired Experience & SkillsExtensive 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 requirementsProven background in electronic laboratory workflow design, configuration, validation, and deployment for global QC operations in regulated biopharmaceutical environmentsStrong expertise in quality systems within biopharmaceutical QC environments, including SOP development, deviation and change control management, CAPA support, audit readiness, and inspection defenseTop 3 Must Have Skills1. 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 biopharma3. Quality systems expertise: SOP development, deviation/change control, CAPA, audit readiness, inspection defenseDay-to-Day ResponsibilitiesInstall and upgrade software and hardware components per scheduleTroubleshoot escalated technical issues and execute repairsLead ELN system process engineering and facilitate new business documentationParticipate in requirements gathering, system design, and configurationCoordinate with site SMEs for ELN Template development and reviewExecute and verify UAT and data migration effortsReview, develop, and support training materialsAssist in planning and executing site instrument qualificationsBasic QualificationsDoctorate degreeMasters degree and 2 years of experienceBachelors degree and 4 years of experienceAssociates degree and 8 years of experienceHigh school diploma / GED and 10 years of experienceThis posting is for Contingent Worker, not an FTE