Senior Quality Assurance Specialist

Sr Quality Assurance Specialist 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. We are looking for a Sr Quality Assurance Specialist to join our Quality team at our new state-of-the-art Frederick, MD facility. This role requires 10hr shift work. Sunday-Wed or Wed-Saturday. Responsibilities: Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative. Coordinate and facilitate Quality Assurance related production and production related activities, including: Approval of electronic batch records and manufacturing labels. Assessment and closure of discrepancies, deviations and change controls requests. Assessment and closure of laboratory investigations. Timely assessment and closure of batch and material hold events. Communicate lot disposition pending issues to stakeholders. Review of batch manufacturing and testing documentation for timely delivery of final product. Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines. Support development of SOPs and review/approve SOPs to ensure quality goals are met Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports. Review and approve manufacturing production records. Compile and verify all batch related documents into a final product lot disposition package. Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA. Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. Guide day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities. Provide periodic updates to stakeholders for deviations, GMP and system issues, non-conforming materials and products and CAPA. Review and disposition raw materials, components, and labels for GMP use. Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies. Facilitate disposition, team meetings and provide process training to staff. Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed. Develop and participate in internal, external and regulatory inspections and audits at the site. May serve as a team representative on cross-functional projects to support more senior colleagues in the function. Act as a mentor of junior staff. Perform other duties as desired. Basic Qualifications: Master's Degree and 4+ years' experience in GMP environment OR Bachelor's Degree and 6+ years' experience in GMP environment OR High School Degree and 11+ years' experience in GMP environment Preferred Qualifications: Proficient in GMPs Proficient in application of QA principles, concepts, industry practices, and standards. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge and good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial. Working knowledge of Risk Management resources (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial. Does this sound like you? If so, apply today! The salary range for this position is: $109,480.00 - $141,680.00. 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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit 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 View email address on click.appcast.io for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. 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. Phenom People