Job DescriptionKnowledge:
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.
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 Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
