QA Specialist II Deviations and Front-Line Support

Join Kite and help shape where our business and medical science goes next. Join Kite and help create more tomorrows.

Job Description

This role is based full time on site at Hoofddorp, including a weekend shift pattern.

Knowledge

• Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Experience in deviation and CAPA management, impact assessments, and root cause investigations.
• Strong technical writing, reporting, and documentation review skills.
• Effective verbal communication, interpersonal, and stakeholder-management skills.
• Proficient in Microsoft Office applications.

Responsibilities

• Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Provide front-line QA support to escalations, ensuring timely actions and clear resolution paths.
• Contribute to the Quality on the floor processes, including shopfloor rounds and real-time QA support.
• Performs QA review and approval of deviations and corrective and preventive action (CAPA).
• Conducts or acts as a coordinator of investigations and CAPA recommendations related to manufactured products.
• Identifies and reports deviations from approved processes and procedures to senior colleagues.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Exercises judgment within well-defined established procedures and practices to determine appropriate action – identifies problems and generates alternatives and recommendations within defined processes.
• Works directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May act as mentor to junior staff with some task management responsibility.
• Contributes to QA projects and participates in cross-functional teams.
• Coordinates planning, organization and implementation of projects within specified objectives.
• Works on more complex, non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
• Additional duties as assigned.

Requirements

• Bachelor’s degree (BS/BA) with 3+ years of relevant experience in a GMP-regulated environment, or Master’s degree (MS) with 1+ years of relevant experience.
• Prior experience in the pharmaceutical or biopharmaceutical industry preferred.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.