Quality Assurance Specialist III

Responsibilities

• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Support scheduling and Quality Management Review activities with oversight 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 in product manufacturing; provide guidance to manufacturing on following controls
• Receipt and disposition of incoming apheresis material
• Oversee and authorize shipment of final product
• Verify and ensure timely issuance of production documents and labels
• Review batch-related documentation and ensure resolution of issues to release and ship products
• Gather and report metrics to measure performance
• Identify and lead continuous improvement actions in QA
• Ensure timely resolution and escalation of issues
• Ensure all product-related Deviations are initiated, investigated and resolved
• Ensure that associated CAPAs are initiated and resolved, as needed
• Perform lot closure activities
• Ensure approval and timely delivery of final product
• Ensure products are manufactured in compliance with regulatory and GMP guidelines
• Provide Quality Assurance support to resolve material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Develop Standard Operating Procedures (SOPs) that meet quality objectives, and contribute to the training program for QA activities
• Provide day-to-day direction, coaching, and mentoring to QA staff, including assigning work, setting priorities, and supporting their 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 and partner with cross-functional teams (Manufacturing, Supply Chain, Site QC, Process Development, Regulatory Affairs, Site QA and QS) within Kite and externally to ensure compliance, resolve issues, and build strong 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
• Provide QA support for new clinical programs (INDs) and New Product Introductions (NPIs), including review and approval of protocols, batch records, specifications, and change controls to ensure GMP readiness for clinical manufacturing
• Partner with Process Development, Manufacturing, QC, Regulatory Affairs, and Supply Chain to establish quality oversight, identify risks, and resolve issues during the start-up and transfer of new clinical programs
• Support Management Review activities and oversee trending of key quality, product and GMP metrics
• 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

Basic Qualifications

• Master's Degree and 3+ years' experience in a GMP environment OR Bachelor's Degree and 5+ years' experience in a GMP environment OR Associate's degree or high school equivalent and 9+ years' experience in a GMP environment

Preferred Qualifications

• Sound knowledge of and ability to apply GMPs in conformance to US, EU and ROW standards
• Proficient in cGMP regulations, quality systems and regulatory requirements
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
• Demonstrates audit and investigation skills, and report writing skills
• Demonstrates strong verbal, technical writing and interpersonal skills
• Ability to effectively negotiate and build collaboration amongst individuals
• Demonstrated supervisory or leadership skills, including the ability to guide, coach, and mentor team members, delegate effectively, and foster a culture of accountability, collaboration, and inclusion
• Strong teamwork and collaboration skills, with excellent interpersonal, verbal, and written communication skills
• Working knowledge and experience with manufacturing investigations, deviations, and CAPA
• Working knowledge of cell culture and/or aseptic manufacturing processes
• Experience supporting early-phase clinical programs, INDs, and/or New Product Introductions (NPIs) in a GMP environment
• Experience writing, evaluating and closing investigations, CAPAs and Change Control records
• Experience with conducting and managing internal and external audits
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
• Proficient in MS Word, Excel, Power Point and other applications
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities