Location: Amsterdam area (Hoofddorp)
Start: Aim is November/December (flexible)
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’ll be joining a newly formed team in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You will be reporting to the Manager Quality Assurance.
Responsibilities (include but are not limited to):
• Quality support to the Site supply Chain, Facility & engineering and QC incoming goods departments
• QA disposition of incoming materials.
• Incoming goods testing and disposition of artwork.
• Inspection and approval of Charged LN2 Shippers
• Performing sales order release in order to ship product to the patient
• Storing and creating batch related documentation and updating our QA tracker
• Review batch-related documentation for media preparation and ensures resolution of issues in order to release.
• Ensure all related Deviations are initiated, investigated and resolved.
• Ensures that associated CAPAs are initiated and resolved, as needed.
• Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
• Contribute to the development and implementation of Quality on the floor processes.
• Giving support to supplier complaints for EU and/or related investigations.
• Liaise with other Kite manufacturing sites, supply chain and CMO’s, where applicable
• Assist in global Supplier Quality Management program.
• Perform other duties as assigned.
• Minimum of 2-3 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• 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
• Identifying, writing evaluating and closing Deviations and CAPA
• General knowledge of aseptic manufacturing processes
• Experience with Change Control practices/strategies
• Strong knowledge of GMP, including GDP, SOPs and quality systems
Are you interested or do you have questions about this position? Do not hesitate and apply to this position so we can get in touch with you ASAP!