QA Documentation 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 day, we seek to establish a direct connection between that purpose and our work.

Reporting to the Sr. Manager, Document Control, the QA Documentation Specialist I supports GMP documentation lifecycle activities within a regulated manufacturing environment. This role is responsible for document control, training document readiness, and GMP record support to ensure compliance, accuracy, and inspection readiness at our Frederick, MD facility.

Shift: Sunday to Wednesday, 7:00 AM to 5:30 PM (4x10 hours)

Responsibilities:

• Provides clerical and administrative support related to documentation processes and systems.

• Pre-approves and routes documents for review and approval in the electronic Document Management System (DMS).

• Approves Document Change Controls and assigns effective dates to documents.

• Pre-Releases documents for training and adds documents to curricula in the electronic Learning Management System.

• Maintains the document archival room.

• Responsible for filing and maintenance of all controlled documents and records. Ensures files are accurate and easily retrievable.

• Creates paper and electronic logbooks to be used in production.

• Issues lot related documentation and labels for manufacturing process.

• Issue GMP documentation for execution including qualification and test methods

• Scans, verifies and archives documentation and records as needed.

• Performs general word processing tasks. Checks format and conformance to document templates.

• Provides support to clients on the process of documents in the DMS. and word processing tasks as needed.

• Participates in function meetings.

• Notifies manager of compliance questions and issues.

• Provides additional support and assistance on tasks and projects as directed by management.

Basic Qualifications:

• Master’s Degree and OR

• Bachelor’s Degree and 2+ years’ relevant industry experience OR

• AA Degree and 4+ years’ relevant industry experience OR

• High School Degree and 5+ years’ relevant industry  experience

Preferred Qualifications:

• Current Good Manufacturing Practices (cGMP) and Pharma Industry experience.

• Label printing with Zebra printers experience.

• Knowledge of Oracle EBS and electronic archive systems (i.e. FileTrail)

• Knowledge of electronic document management systems (Document Locator, Documentum, Veeva or equivalent)

• Knowledge of MS Word, Excel, Power Point, and Adobe Pro

 

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 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.