Kitepharma

Kitepharma

Sr QA Specialist

United States - Maryland - Frederick · Senior

Sponsorship not specified$124k-$160kDetected 26 days ago
Process ImprovementGMPCommunicationWritingMicrosoft OfficeHACCP

About the role

  • We're here for one reason and one reason only - to cure cancer.
  • We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm.
  • Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Responsibilities

  • Manages the daily workflow of the QA Tech services team.
  • Develops and Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Conducts or acts as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products, and performs QA review and approval of complex deviations and CAPAs.
  • Support the development of Risk Management documents using tools such Failure Mode Effects Analysis (FMEA), etc.
  • Uses/Develops KPI's to identify and solve problems within the quality process.
  • Identifies deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Leads QA projects or contributes to cross functional projects using Lean concepts.
  • Provides support to incoming escalations from various stakeholders, ensuring all immediate actions are taken and a path forward established.
  • Demonstrates ability to effectively manage multiple projects/priorities.

Requirements

  • 7+ years of relevant experience in a GMP environment related field and a BS/BA.
  • 5+ years of relevant experience and a MS.

Nice to have

  • These considerations mean actual compensation will vary.

Compensation

  • $123,930.00 - $160,380.00.
  • Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
  • These considerations mean actual compensation will vary.
  • 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*.
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Company info

  • Every moment is dedicated to developing treatments and every action moves us one step closer to our goal.
  • But we're not finished yet.
  • 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.

Equal opportunity

  • In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

This listing is sourced directly from Kitepharma's careers page and normalized into a canonical job model.