QA Specialist I

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.

We are seeking a highly motivated individual to join us as a Quality Assurance this role you will support the activities of the Quality Assurance department at Kites Frederick MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality systems procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

***Shift is Sun-Wed 5:00 pm- 3:30 am***

Responsibilities (included but not limited to):

• Provide QA support on the floor for production in manufacturing and in the QC labs.

• Ensure process control measures are in place and followed in product manufacturing.

• Perform apheresis accession of incoming patient material.

• Perform shipment authorization of final product.

• Review batch-related documentation and ensure resolution of issues to release and ship product.

• Real-time review of exceptions Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) on the manufacturing floor.

• Gather and report metrics to measure performance.

• Identify and participate in continuous improvement activities.

• Ensure timely resolution and escalation of issues.

• Ensure quality records are initiated for deviating events observed on the floor.

• Ensure approval and timely delivery of final product.

• Ensure products are manufactured in compliance with regulatory and GMP guidelines.

• Provide Quality Assurance support resolving material in-process product final product environmental facility and equipment manufacturing issues.

• Additional duties as assigned.

• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR

• BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

• High School diploma and 5 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Preferred Qualifications:

• BS/BA 2 yrs. experience in a GMP related field within a biotechnology biologics or pharmaceutical manufacturing facility.

• Working knowledge and ability to apply GMPs in conformance to U.S. EU and ROW standards

• Ability to effectively negotiate and build collaboration amongst individuals

• Strong teamwork and collaborative skills

• Experience with manufacturing investigations deviations and CAPA.

• General knowledge of aseptic manufacturing processes.

• Proficient in MS Word Excel Power Point and other applications.

• Strong interpersonal verbal and written communication skills

• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities

• Willingness to think outside of the box and adapt best practices to a small but growing environment

• Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational prioritization and time management proficiencies

• Self-motivated detail-oriented and willing to accept temporary responsibilities outside of initial job description.

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.