Netherlands flag

QA Specialist I

Netherlands - HoofddorpQualityRegular

Job Description

Kite, A Gilead Company Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. Our company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

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 in this mission?

Knowledge:

  • Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
  • Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
  • Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
  • Demonstrates audit and investigation skills, and report writing skills.
  • Demonstrates strong verbal, technical writing and interpersonal skills.
  • Demonstrates proficiency in Microsoft Office applications.
     

Specific Education & Experience Requirements:

  • 2+ years of relevant experience in a GMP environment related field and a hbo diploma, BS or BA.
  • Prior experience in pharmaceutical industry is preferred.

Specific Job Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures to ensure quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.
  • Participates in the writing of annual product reviews.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.
  • May assist with compliance audits as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
  • Normally receives no instruction on routine work, general instructions on new assignments.


If you thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of our exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us. If you are looking for an environment where you can learn and grow this is a perfect opportunity to join Kite. If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.

Would you like to know more before you apply?

Please visit us at www.kiteamsterdamcareers.com. Only candidates in possession of a alid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.