QA Specialist I

Arbeitsbeschreibung

Quality Assurance Specialist I

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day‑to‑day work. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist I. In this role, you will support activities of the Quality Assurance department within the Global QA organization, supporting the Global Raw Materials and Reagents Center of Excellence (GRM&R CoE).

The Quality Assurance Specialist I is responsible for supporting compliance with the quality system, identifying and assessing regulatory and quality risks, and providing day‑to‑day QA oversight of raw material and reagent processes within GRM&R.

Key Responsibilities (included but not limited to):

• Perform a wide variety of activities to ensure compliance with applicable quality objectives, regulatory requirements, and GMP guidelines

• Provide QA support through review and approval of raw material batch disposition records

• Review batch‑related documentation, ensure resolution of issues, and support timely release and shipment of raw materials

• Ensure approval and timely release of raw materials to the Global Network

• Verify and ensure timely issuance of production and testing documentation

• Ensure process control measures are in place and followed for raw material testing and provide guidance to laboratories on adherence to controls

• Provide document control support, including issuance of testing forms for the site/laboratory and maintenance of electronic document organization and alignment

• Ensure all raw material‑related deviations are initiated, investigated, and appropriate CAPAs are developed and completed

• Serve as Quality Approver on quality records, including LIRs, deviations, and CAPAs

• Gather, trend, and report metrics to measure performance and support continuous improvement activities

• Identify and support continuous improvement initiatives within QA

• Ensure timely resolution and appropriate escalation of quality issues

• Participate in the development and maintenance of Standard Operating Procedures (SOPs) to ensure quality targets are met

• Participate in the development and execution of QA training activities

• Perform other duties as assigned

Basic Qualifications:

• Bachelor’s degree (BS) with a minimum of 2 years of relevant experience in a GMP‑regulated environment

• Associate’s degree (AA) with a minimum of 4 years of relevant experience in a GMP‑regulated environment

• Prior experience in the pharmaceutical or biotechnology industry is beneficial

Preferred Qualifications:

• Working knowledge of GMP requirements and ability to apply GMP principles in conformance with U.S., EU, and Rest‑of‑World regulations

• Experience supporting manufacturing or laboratory investigations, deviations, and CAPAs

• Strong interpersonal, verbal, and written communication skills

• Ability to collaborate effectively and build productive working relationships across teams

• Proficient in Microsoft Word, Excel, PowerPoint, and other standard business applications

• Comfortable working in a fast‑paced environment with the ability to adjust workload based on changing priorities

• Demonstrated organizational, prioritization, and time‑management skills while managing multiple assignments

• Self‑motivated, detail‑oriented, and willing to take on temporary responsibilities outside of the initial job description

• Willingness to adapt best practices to evolving processes and business needs