Sr QA Specialist

Kite Pharma • Frederick, MD

5d

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

• Proficient in GMPs and/or GLPs.
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• 7+ years of relevant experience in a GMP environment related field and a BS/BA.
• OR 5+ years of relevant experience and a MS.

Nice To Haves

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Responsibilities

• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
• Coordinate and facilitate Quality Assurance related production and production related activities, including: Approval of electronic batch records and manufacturing labels.
• Assessment and closure of discrepancies, deviations, CAPAs and change controls requests.
• Completion of change actions for change controls.
• Assessment and closure of laboratory investigations.
• Timely assessment and closure of batch and material hold events.
• Communicate lot review pending issues to management.
• Review and disposition of batch manufacturing documentation for timely disposition of final product.
• Ensure products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
• Support development of SOPs and review/approve SOPs to ensure quality objectives are met.
• Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
• Review and approve manufacturing production records.
• Review and disposition of raw materials.
• Review and compile all batch related documents into a final product lot disposition package.
• Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPAs.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
• Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPAs.
• Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPAs.
• Review and disposition raw materials, media/reagents, components, and labels for GMP use.
• Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Report to management as needed.
• Manage and participate in internal, external and regulatory inspections and audits.
• Participate in continuous improvement projects.
• May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
• Acts as a mentor to junior staff.
• Provide process training to team, as needed.
• 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: Senior