QA Specialist III
Netherlands - HoofddorpQualityRegularJob Description
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
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.
As Quality Assurance Specialist you will perform a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
In your new new role you will:
Develop and Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Review manufacturing, environmental monitoring and quality control data for in process and finished products.
Compile final product binders for the QP release and perform QA disposition.
Contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Conduct or serve 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 CAPA and contributes to cross functional investigations.
Identify deviations from approved procedures and processes, evaluates impact assessments and develops solutions for complex problems.
Write and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
Assist with external audits/inspection processes as required, and acts as an SME for QA procedures and processes during inspections and audits.
About you
You have a BSc degree in Life Science or similar disciplines.
You have progressive experience in quality or manufacturing in a pharmaceutical or biotechnology companies.
You have previously worked according to GMP guidelines, SOPs and quality systems.
You are experienced in identifying, writing evaluating and closing Deviations and CAPA
You have worked with Change Control practices/strategies.
Good interpersonal, verbal and written communication skills in English
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Proficient in Outlook, MS Word, Excel, Power Point and other applications
Does it sound like you and you would like to know more before you apply? Please visit us at www.kiteamsterdamcareers.com,