Quality Control Specialist

Specialist Quality Control

Location: Thousand Oaks, CA

Onsite Flexibility: Remote

Contract Details:

• Position Type: Contract
• Contract Duration: 24 months
• Pay Rate: $40.00–$44.00 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

This is a Specialist role supporting the site business process owners, templators, and end users of the QC ELN and consumable management systems. The role involves supporting and troubleshooting issues at seven QC organizations in templating, template qualification, and using the established ELN Biovia SmartLab and consumable management systems. Responsibilities include reviewing and approving system user access, conducting periodic reviews, and authoring SOP revisions. The candidate will also collaborate with technology functions to resolve system issues, drive alignment across the QC network, and provide audit support. Expertise in data integrity requirements, problem-solving, and independent work is essential, with preferred experience in Biovia SmartLab and CIMS.

Key Responsibilities

• Support of 7 QC organizations for templating, template qualification, and use of ELN and consumable management systems including troubleshooting issues
• Business owner review and approval of system (privileged, non-privileged) user access reviews, system periodic reviews, annual audit trail reviews
• Collaboration with technology function to ensure timely troubleshooting and resolution of system issues
• Authoring of SOP revisions related to the systems supported
• Review of system documentation for system changes (system description, design specification, requirements specification, data integrity assessment)
• Provision of input to deviations, and guidance on appropriate corrective/preventative actions
• Driving alignment and standardization across the QC network as it relates to the systems supported
• Review of training and submission of system access requests
• Lead biweekly network meeting
• Audit support
• Coordinate system downtime windows
• Development of queries/reports
• Review and approve application service/infrastructure requests, change approvals, problem records

Required Skills

• Experience as business process owner
• Ability to problem solve and troubleshoot system issues
• Ability to work independently and deliver right first time results
• Knowledge of data integrity requirements of QC systems
• Ability to prioritize appropriately based on criticality
• Strong, clear, concise communication skills
• Document authoring and review capabilities

Preferred Skills

• Experience in Biovia SmartLab and CIMS
• Knowledge of SQL, Tableau
• Audit support experience

Education Requirements

• B.S. (Bachelor's degree) with a minimum of 5 years of experience in QC, OR:
• Doctorate degree, OR
• Master's degree and 2 years of experience, OR
• Bachelor's degree and 4 years of experience, OR
• Associate's degree and 8 years of experience, OR
• High school diploma / GED and 10 years of experience

Required Experience

• Minimum 5 years of experience in QC (per primary qualification)

Work Environment / Physical Requirements

• Interview process: 1–2 rounds of interviews; first round will be panel style

Important Notes

• Red flags for this role include lack of GMP experience and no prior experience in autonomous roles

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.