QA Specialist I

Kite Pharma•Frederick, MD

17h•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 single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us on this mission? We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives. Shift is Wed - Sat 5:00 pm- 3:30 am

Requirements

MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar)
BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Nice To Haves

BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
Ability to effectively negotiate and build collaboration amongst individuals
Strong teamwork and collaborative skills
Experience with manufacturing investigations, deviations, and CAPA.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong interpersonal, verbal and written communication skills
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Willingness to think outside of the box and adapt best practices to a small, but growing environment
Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Responsibilities

Provide QA support on the floor for production in manufacturing and in the QC labs.
Ensure process control measures are in place and followed in product manufacturing.
Perform apheresis accession of incoming patient material.
Perform shipment authorization of final product.
Review batch-related documentation and ensure resolution of issues to release and ship product.
Real-time review of exceptions, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs) on the manufacturing floor.
Gather and report metrics to measure performance.
Identify and participate in continuous improvement activities.
Ensure timely resolution and escalation of issues.
Ensure quality records are initiated for deviating events observed on the floor.
Ensure approval and timely delivery of final product.
Ensure products are manufactured in compliance with regulatory and GMP guidelines.
Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume