Job Description

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.

Reporting into the Sr. Manager, Document Control we are looking for a QA Documentation Specialist I to work in our state-of-the-art facilities here in Frederick, MD.

The standard work week for this position is 4 days a week / 10 hour shifts Wednesday-Saturday.

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 logbooks to be used in production.

• Issues lot related documentation and labels for manufacturing process.

• Issue GMP documentation for implementation 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. Ensure the correct and timely input of database entries.

• 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.

Basic Qualifications:

• Master’s Degree and OR

• Bachelor’s Degree and 2+ years’ experience in Document Control, MS Word, Excel, PowerPoint, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent) OR

• AA Degree and 4+ years’ experience as noted above OR

• High School Degree and 5+ years’ experience as noted above

Preferred Qualifications:

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

• Labels printing with Zebra printers experience.

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

• Good interpersonal communication skills

• Ability to function efficiently in a team and independently

• Adaptable and comfortable in a collaborative and inclusive company environment

#QCQA123

#IND123

The salary range for this position is: $76,245.00 - $98,670.00. Gilead 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.

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.

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 jobs in France:

Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com