Quality Systems Specialist II

Kite PharmaEl Segundo, CA
3h

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 Job Description Key Responsibilities Perform a variety of activities to ensure compliance with applicable regulatory requirements. Carry out basic administrative tasks supporting maintenance of programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs). Review manufacturing, environmental monitoring, and quality control data for in-process and finished products under guidance from senior colleagues. Follow general instructions on routine work and detailed instructions on new assignments.

Requirements

  • AA degree with at least 5 years of relevant experience in a GMP-related field.
  • OR BS/BA with at least 4 years of relevant experience in a GMP-related field.
  • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Basic knowledge of FDA/EMEA standards and quality systems.
  • Good verbal, written, and interpersonal communication skills.
  • Working knowledge of Microsoft Office applications.

Responsibilities

  • Perform a variety of activities to ensure compliance with applicable regulatory requirements.
  • Carry out basic administrative tasks supporting maintenance of programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Review manufacturing, environmental monitoring, and quality control data for in-process and finished products under guidance from senior colleagues.
  • Follow general instructions on routine work and detailed instructions on new assignments.

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.
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