QA SpecialistNetherlands - HoofddorpQualityRegular
As a Quality Assurance Specialist you will provide compliance guidance to frontline departments involved in the operation of the manufacturing facility. Your role will be in a dynamic environment with the possibility to experience frontline QA support work in a commercial cell therapy manufacturing facility. You will join a diverse, highly motivated and driven team, and are required to be a self-starter who is proactive. The key to success in the role is to ensure collaboration and communication is efficient and open.
Kite, A Gilead Company
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
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. Our core business is to ensure frontline operational activities and departments are supported, and to do so we have a shift structure in place to support 7 days per week with extended early and late coverage on site and on call service.
You will be reporting to the Sr. Manager Quality Assurance.
Responsibilities (include but are not limited to):
- Review batch-related documentation, and ensure resolution of issues to release product.
- Ensure all product-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 maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
- Contribute to the maintenance and reporting of Change Control metrics for Quality Systems in support of the Management Review.
- Contribute to the development of Quality on the floor processes, including GEMBA walks and deviation triage.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Perform other duties as assigned.
- A BSc degree and minimum 6 years of experience in the Biotech and/or Pharmaceutical Industry
- Minimum of 5 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
- Willing and able to work in shifts (no night shift)
- Demonstrated ability to train staff
- 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
- Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
- 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
As part of our recruitment process, you will be asked to complete a short 20-minute online Occupational Personality Questionnaire (OPQ) and/or a capability test.
Only candidates in possession of a valid 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.