QA Documentation Specialist I

Kite Pharma • Frederick, MD

7d • 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. 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)

Requirements

• 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

Nice To Haves

• 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

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.

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: Entry Level