For our client, a worldwide leader in innovative cancer immunotherapies, we seeking to recruit highly motivated QA Specialist for 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.
- 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.
- You will be reporting to the Manager Quality Assurance.
- Minimum of 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, 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
What do we offer
- Temporary agency contract via Kelly Services
- Start date: 01/1172021, 12 months project with possible extension or conversion contract client
- Salary indication depending on experience
When interested please react through the application process with your English resume.
T: +31 (0)639694482
About Kelly Services
It's more than a job. It's passion.
Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.
At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.
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Met oog op de AWGB (Algemene Wet Gelijke Behandeling) verwelkomt Kelly Services sollicitaties van iedere geschikte kandidaat, ongeacht etniciteit, geslacht, beperking, religieuze overtuiging, seksuele geaardheid of leeftijd.
Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.