QA Documentation Associate II

Kite Pharma • Oceanside, CA

2d

About The Position

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 The QA Documentation Associate II is responsible for supporting the organization’s document management processes to ensure compliance with regulatory requirements and internal quality standards. This role involves maintaining accurate records, managing controlled documents, and assisting with audit readiness activities to support both clinical and commercial manufacturing operations.

Requirements

• 3+ years related experience with High School Diploma OR 2+ years related experience with Associate's Degree OR 0+ years related experience with Bachelor of Science Degree

Nice To Haves

• Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
• Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
• Demonstrates basic knowledge of Electronic Document Management Systems (EDMS).
• Experience in Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)
• Keeps abreast of the basic requirements for compliance in own work area.
• Demonstrates detail orientation and problem solving skills.
• Demonstrates proficiency in Microsoft Office applications.
• Demonstrates ability to work independently as well as effectively in a team environment.
• Demonstrates strong verbal, written, and interpersonal communication skills.

Responsibilities

• Ensures the correct and timely implementation of Change Requests (CR), Document Change Controls (DCCs) and Documents.
• Issue and manage controlled logbooks as applicable.
• Issue and reconcile controlled documents including protocols, forms used for execution including qualification and test methods
• Supports the distribution and maintenance of GXP documentation.
• Provides clerical and administrative support related to documentation processes and systems.
• Maintains documentation manuals to ensure accuracy and current information.
• Scans, verifies and archives documentation and records.
• Ensures the correct and timely input of database entries, verifies own work.
• Performs general word processing tasks and support.
• Checks format and conformance to document templates.
• Verifies own work.
• Provides support for internal and regulatory audits/inspections as required.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED