Quality Control Specialist III

For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals. 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. Join us in our mission! Kite is seeking a highly motivated individual to join Kite as a QC Specialist III, Global Quality Control, to provide Quality Control support of Global Raw Materials and Reagents Center of Excellence (GRM&R CoE). In this role you will be responsible for the testing, release, and characterization of raw material and reagents, within a Good Manufacturing Practices (GMP) environment. Responsibilities: Independently performs routine Raw Materials release testing by following established procedures as written. Participates as needed in the testing of raw materials by following analytical methods compendial methods and/or analytical procedures such as, pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel/Western Blot, FT-IR, HPLC, LC-MS, PCR, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays, and other applicable methods for the testing of Raw Materials and Reagents. Responsible for equipment lifecycle, maintenance, and calibration, is performed in a timely manner, as assigned. Responsible for the investigation and evaluation of non-conformances related to laboratory testing, laboratory OOS investigations, deviations, CAPAs and change controls, as assigned. Responsible for QC Testing Training program, as assigned. Supports Audits. Provides data analysis and trending. Provides technical solutions to a wide range of difficult problems. Leads/coordinates Quality Control and cross-functional projects with limited direction. Training and cross-training of junior employees, Drive department goals/objectives. Authors and revises Standard Operating Procedures. Compile data for trending or investigation purposes or conduct research in regulatory guidance and peer-reviewed journals. Performs GMP documentation with attention to detail. Gathering of documentation and data entry. Documentation and test record review. Keeps laboratory area clean and ensures waste is properly disposed. Keeps laboratory reagent and supply inventory. Supports the department with other duties as assigned. Basic Qualifications: Master’s Degree and 3 years’ experience in the biotech/biopharmaceutical setting OR Bachelor’s Degree and 5 years’ experience in the biotech/biopharmaceutical setting OR Associate and 7 years' experience in the biotech/biopharmaceutical setting OR High School Diploma/GED and 9 years' experience in the biotech/biopharmaceutical setting Preferred Qualifications: Thorough understanding and experience operating within an GMP environment. Working knowledge and understanding of analytical techniques to include HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents within an GMP environment. Experience leading OOS’s, CAPAs, change controls, deviations, and laboratory investigations. Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry. Preferred, Knowledge of aseptic technique and previous experience with cell culture. Exceptional attention to detail and ability to keep track of multiple ongoing projects. Experience writing, reviewing, or executing standard operating procedures, protocols, and reports. Ability to independently perform duties and be adaptable to a dynamic and fast-paced environment. Excellent interpersonal and organizational skills. Strong project and time management skills. Excellent oral and written communication skills. Proficiency in MS Word, Excel, Power Point and other applications. Experience using laboratory and quality systems (e.g., Empower). #QCQA123 #IND123 #LI-ML1 The salary range for this position is: $101,830.00 - $131,780.00. 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: 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 contact careers@gilead.com for assistance. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. 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 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. 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. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority. The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.