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Frederick, Maryland, United States
Onsite
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.
Specific Job 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, CAPAs and change controls requests.
Completion of change actions for change controls.
Assessment and closure of laboratory investigations.
Timely assessment and closure of batch and material hold events.
Communicate lot review pending issues to management.
Review and disposition of batch manufacturing documentation for timely disposition of final product.
Ensure products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
Support development of SOPs and review/approve SOPs to ensure quality objectives are met.
Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
Review and approve manufacturing production records.
Review and disposition of raw materials.
Review and compile 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 CAPAs.
Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPAs.
Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPAs.
Review and disposition raw materials, media/reagents, components, and labels for GMP use.
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
Manage and participate in internal, external and regulatory inspections and audits.
Participate in continuous improvement projects.
May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
Acts as a mentor to junior staff.
Provide process training to team, as needed.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Knowledge:
Proficient in GMPs and/or GLPs.
Proficient in application of QA principles, concepts, industry practices, and standards.
Demonstrates ability to effectively manage multiple projects/priorities.
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 tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
Basic Qualifications:
7+ years of relevant experience in a GMP environment related field and a BS/BA.
OR
5+ years of relevant experience and a MS.
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.
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 ApplicantAccommodations@gilead.com 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.
Please apply via the Internal Career Opportunities portal in Workday.