QA Documentation Specialist I

Gilead Sciences • Frederick, MD

2d • $80,325 - $103,950 • Onsite

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.

Requirements

• 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.
• 5+ years of relevant experience in the pharmaceutical industry and a High School diploma.
• 3+ years of experience and AA degree.

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.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree