Quality Assurance Associate
Did you recently graduate with a Degree in Physical, Chemical or Biological Sciences, and would you like to start your career in Quality Assurance? Then you might be our new colleague!
We are currently looking for a QA Associate for the Quality Engineering (QE) Expansion Drug Substance Manufacturing (DSM) team in Hillerød. In this role you will support on Quality Assurance deliverables at our DSM Expansion Project.
Activities include, but are not limited to, assist with review and approval of Validation and Engineering documents including technical documents requiring QA approval and related deviations and GMP procedures. You will be the QA contact person for the project change controls and CAPA’s. Furthermore, you will be an active member of working groups where quality input is needed. You will manage the coordination of daily tasks and training in close collaboration with QA Engineering Project Lead for the DSM Expansion Project.
The QE Expansion DSM team is a small team in which you will be able to work with different expansion projects and several stakeholders. You will have a good opportunity to get introduced to working in a QA organization and get familiar working in a Biopharmaceutical Contract Development Manufacturing Organisation (CDMO).
You have recently finalized a Bachelor or Master degree in Physical, Chemical or Biological Science or equivalent. You have knowledge of GMP and preferably gained some working experience in Manufacturing, Quality Control or Quality Assurance. Furthermore you possess good communication skills and fluency in English
As a person you are a high performing and driven individual who values strong teamwork at all levels and perform their work with an open mind and a sense of humour. You are a motivated team-player with a “go-do” attitude. You are flexible and take ownership and responsibility of your assignments.
Please upload your CV and cover letter as soon as possible as we will invite candidates on a continuous basis. The job advertisement will be removed when the right candidate has been identified.
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.
Our manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. Our large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance. On June 9, 2020 FUJIFILM Corporation has announced the investment of approx. 6 billion Danish kroner into the site to double the manufacturing capacity, to add a fill finish capacity and to enhance the assembly, label and pack services on site. The investment is expected to create approx. 300 new jobs.
At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the biopharmaceutical industry. We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, everyone is a valuable contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.