QA Specialist II

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

REQUIREMENTS

• Review batch-related documentation and ensure resolution of issues to release product.
• Perform comprehensive quality review of batches for disposition.
• Ensure process control measures are in place and followed in product manufacturing.
• Ensure all product-related Deviations are initiated investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved as needed.
• Generate and update procedures forms and other documents.
• As assigned manage and provide QA oversight for other processes including training warehouse /inventory redose new product introductions etc.
• Maintain production (finite ) disposition and team schedules
• Represent Disposition or QA Ops at plant and multi-site scheduling meetings.
• Provide QA representation at multi-site disposition meetings
• Provide QA representation on projects and at team meetings
• Maintain metrics related to product disposition in support of the Management
• Review and for continuous improvement.
• Support and participate in inspections and audits.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

QUALIFICATIONS

• Bachelors degree in Life Sciences Biology Chemistry Engineering or a related scientific discipline.
• Minimum 3-4 years of experience in a regulated pharmaceutical biotechnology cell therapy medical device or GMP manufacturing environment.
• Working knowledge of cGMP regulations FDA requirements and applicable quality systems.
• Experience reviewing and approving GMP documentation including batch records deviations CAPAs change controls and investigations.
• Strong attention to detail with the ability to identify compliance risks and quality concerns.
• Demonstrated ability to make quality decisions based on data procedures and regulatory requirements.
• Effective written and verbal communication skills with the ability to interact across Quality Manufacturing Supply Chain and Technical Operations.
• Proficiency in electronic quality management systems document management systems and Microsoft Office applications.

PREFERRED QUALIFICATIONS

• 2-3 years of QA Operations batch disposition product release or manufacturing quality experience in biotechnology cell therapy or pharmaceutical manufacturing.
• Experience performing lot disposition and product release activities in a GMP environment.
• Knowledge of cell therapy manufacturing processes and associated quality requirements.
• Experience with electronic batch records Veeva Vault MES SAP or similar quality/manufacturing systems.
• Strong understanding of deviation management risk assessments change control and data integrity principles.
• Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining compliance.
• Experience supporting internal and external audits and regulatory inspections.
• Demonstrated ability to influence cross-functional teams and drive quality-focused decision making.

The salary range for this position is: $92820.00 - $120120.00. Kite considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.