Quality Assurance Specialist III

Gilead Sciences • Santa Monica, CA

1d • $107,185 - $138,710 • Onsite

About The Position

Kite Pharma is seeking a motivated, collaborative Quality Assurance Specialist III for its RDMC manufacturing site. The role ensures compliance through objective evaluation of process performance and product quality, and provides QA support for new clinical programs, including early-phase Investigational New Drug (IND) studies and New Product Introductions (NPIs). The specialist ensures adherence to procedures and assesses regulatory and quality risks in accordance with regulatory agency guidance and Kite’s quality objectives. The position is accountable for routine QA responsibilities related to production and disposition of products manufactured and tested on behalf of Kite Pharma.

The role provides daily on-site QA support for clinical programs and manufacturing, including QA On-The-Floor support. It oversees quality processes from receipt of incoming apheresis material through final-product disposition, release, and shipment. The specialist supports investigations, deviations, CAPAs, change controls, lot closure, audits, inspections, management reviews, and continuous improvement. The role also supports product development, technical transfers, new clinical program start-up, and viral vector manufacturing.

The specialist provides day-to-day direction, coaching, and mentoring to QA staff; leads cross-functional collaboration; and contributes to SOPs and QA training. The position may also perform other duties as assigned.

Requirements

• Master’s degree and 3 or more years of experience in a GMP environment, or a bachelor’s degree and 5 or more years of GMP experience, or an associate degree or high school equivalent and 9 or more years of GMP experience.
• Sound knowledge of and ability to apply GMPs in conformance with US, EU, and rest-of-world standards.
• Proficiency in cGMP regulations, quality systems, and regulatory requirements.
• Proficiency in GMPs and/or GLPs and in applying QA principles, concepts, industry practices, and standards.
• Audit, investigation, and report-writing skills.
• Strong verbal, technical-writing, and interpersonal skills; ability to negotiate effectively and build collaboration.
• Supervisory or leadership skills, including guiding, coaching, mentoring, delegating, and fostering accountability, collaboration, and inclusion.
• Teamwork and collaboration skills, with strong interpersonal, verbal, and written communication skills.
• Working knowledge and experience with manufacturing investigations, deviations, and CAPA.
• Ability to work with multiple projects simultaneously and demonstrate organizational, prioritization, and time-management proficiency.
• Comfort working in a fast-paced small-company environment with minimal direction and adjusting workload as priorities change.
• Proficiency in MS Word, Excel, PowerPoint, and other applications.

Nice To Haves

• Working knowledge of cell culture and/or aseptic manufacturing processes.
• Experience supporting early-phase clinical programs, INDs, and/or NPIs in a GMP environment.
• Experience writing, evaluating, and closing investigations, CAPAs, and change-control records.
• Experience conducting and managing internal and external audits.
• Ability to conduct or coordinate investigations and CAPA recommendations related to manufactured products.
• Experience working with Research and Development, Process Development, and Manufacturing during new product start-ups, including INDs and NPIs, and identifying routine quality checkpoints for new products and processes.
• Ability to assist with compliance audits.
• Experience writing and/or implementing changes to controlled documents such as SOPs, specifications, and methods.
• Strong knowledge of Six Sigma, LEAN, and root-cause-analysis tools for identifying and correcting deviations.
• Willingness to think outside the box and adapt best practices.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside the initial job description.

Responsibilities

• Support scheduling and Quality Management Review activities, including oversight and trending of key quality, product, and GMP metrics.
• Maintain a daily on-site QA presence to support clinical programs, including new INDs and NPIs, and the clinical manufacturing process.
• Provide QA On-The-Floor support for production.
• Ensure process control measures are in place and followed during product manufacturing, and guide manufacturing staff on following those controls.
• Receive and disposition incoming apheresis material.
• Oversee and authorize shipment of final product.
• Verify timely issuance of production documents and labels.
• Review batch-related documentation and ensure issues are resolved to enable product release and shipment.
• Gather and report performance metrics.
• Identify and lead continuous improvement actions in QA.
• Ensure timely resolution and escalation of issues.
• Ensure product-related deviations are initiated, investigated, and resolved, and that associated CAPAs are initiated and resolved as needed.
• Perform lot-closure activities and ensure approval and timely delivery of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Provide QA support to resolve material, in-process product, final product, environmental, facility, and equipment manufacturing issues.
• Develop SOPs that meet quality objectives and contribute to training for QA activities.
• Provide day-to-day direction, coaching, and mentoring to QA staff, including assigning work, setting priorities, and supporting professional development.
• Lead and facilitate cross-functional teams and meetings to drive issue resolution and continuous improvement and foster a collaborative, accountable, and inclusive team culture.
• Collaborate with Manufacturing, Supply Chain, Site QC, Process Development, Regulatory Affairs, Site QA and QS, and external partners to ensure compliance, resolve issues, and build working relationships.
• Support quality assessments of internal operations to analyze quality compliance and assess risk.
• Provide QA guidance on product-development projects and technical-transfer activities.
• Support new clinical programs, including INDs and NPIs, by reviewing and approving protocols, batch records, specifications, and change controls for GMP readiness in clinical manufacturing.
• Partner with Process Development, Manufacturing, QC, Regulatory Affairs, and Supply Chain to establish quality oversight, identify risks, and resolve issues during start-up and transfer of new clinical programs.
• Support regulatory inspections, internal audits, and external audits from partners.
• Review technical process and analytical reports as appropriate.
• Support the viral vector manufacturing site.
• Perform other duties as assigned.

Benefits

• Discretionary annual bonus may be available.
• Discretionary stock-based long-term incentives may be available; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED