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.
Knowledge:
Demonstrates advanced knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
Demonstrates general knowledge of the processes and impact of document control, and the relationship between the document change process and products.
Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
Keeps abreast of the basic requirements for compliance in own work area.
Demonstrates a high degree of attention to detail
Demonstrates problem solving skills.
Demonstrates proficiency in Microsoft Office applications Oracle environment.
Demonstrates strong verbal, written, and interpersonal communication skills.
Specific Education & Experience Requirements:
5+ years of relevant experience in the pharmaceutical industry and a High School diploma.
3+ years of experience and AA degree.
Specific Job Responsibilities:
Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents.
Maintains documentation manuals to ensure accuracy and current information.
Ensures the correct and timely input of database entries, verifies own work.
Supports the distribution and maintenance of GXP documentation.
Scans, verifies and archives documentation as needed
Recommends process improvements and proposes changes.
Provides support with internal and regulatory audits/inspections as required.
Provides user training for electronic systems (as applicable).
Creates and maintains document templates.
Assists with the periodic review process.
Supports the maintenance of monthly document control metrics.
Performs general word processing tasks and support. Checks format and conformance to document templates, verifies own work.
Provides additional support and assistance on tasks and projects as directed by management.
Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.
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.
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