QA Specialist I

We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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. Job Description 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 on this mission? We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's 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 The salary range for this position is: $80,325.00 - $103,950.00. 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: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * 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 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: 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 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 contact [email protected] for assistance. For more information about equal employment opportunity protections, please view the 'Know 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. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Change The World With Us Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.