QA Specialist I

Kite Pharma • Frederick, MD

3d • Onsite

About The Position

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 Sun-Wed 5:00 pm- 3:30 am

Requirements

• MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR 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) OR 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) OR 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

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

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