Sr. Specialist, Quality Assurance Operations

We are seeking a highly motivated individual for the role of Senior Specialist, QA Operations to work in this exciting new area of cancer immunotherapy. You will report into the Quality Records Team Manager of QA Operations and be based in our El Segundo site and associated clinical and commercial manufacturing and testing laboratories.

Responsibilities:

• Provide QA oversight and approval of deviation, OOS, and change control records. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
• Provide QA oversight and approval of CAPAs. Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
• Weekend work and alternate shift may be required

Additional Responsibilities may include:

• Ensure process control measures are in place and followed in product manufacturing.
• Review batch-related documentation, and ensure resolution of issues to release product.
• Support, and as necessary participate in QA on the floor processes, including batch record review.
• Review and approve manufacturing production records.
• Generate and update procedures and forms as needed.
• Perform Product Disposition and Lot Closure.
• Oversee the packaging and shipping process; authorize shipment.
• Perform disposition of incoming materials, components, and labels for GMP use.

Qualifications:

• Bachelor's degree in the biological sciences or related field and minimum of 8 years' experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards

• Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Must be able to work on multiple records simultaneously and demonstrate organizational, prioritization, and time management skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with manufacturing investigations, deviations, and CAPA.
• Experience with change control practices and strategies.
• Knowledge of equipment, facility, and utility IQ/OQ/PQ.
• Proficient in MS Word, Excel, Power Point and other applications

#LI-MY1

IND123

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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic 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 laws. In 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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

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

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

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

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.