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Quality Control Specialist

About the job

Are you energized by providing 1st class support, have a “can do” attitude and an ability to anticipate and prevent issues before they materialize? Are you a good coordinator with a big picture mind-set who thrive with close collaboration involving multiple stakeholders? Would you like to be part of an engaged team of colleagues who work together to ensure timely deliveries, take pride in providing high service to our customers and colleagues and enjoys each other’s company? Then this position as Quality Control Specialist for our QC Instruments function might be the right match for you!

About the department

In QC at FUJIFILM Diosynth Biotechnologies (FDB) we are approximately 90 people supporting manufacturing both on-site and as a CLO. We test drug substance, drug product, all the raw materials used in the on-site manufacturing processes as well as stability samples. We have a number of testing teams and five supporting teams, QC Instruments is one of them.

In QC Instruments we work cross-functionally and have stakeholders from many departments on-site.Our primary tasks include ensuring instruments and associated software are qualified and maintained in accordance with cGMP guidelines, support business stakeholders and identify and implement process enhancements to instrument infrastructure and usage. We have a very diverse range of tasks and work closely together as a unit utilizing each other’s inputs and strengths.

About the position

You will serve as a bridge between the QC Instrument team and its stakeholders and help ensure we always deliver 1st class support and identify areas where we can further improve our processes. You will coordinate instrument maintenance and qualification to ensure smooth collaboration between multiple stakeholders. You will drive the Windows 10 instrument upgrade project. Moreover, you will create and maintain GMP documents in collaboration with stakeholders and QA. Lastly, you will  utilize your knowledge to work closely together with your future colleagues as a team to innovate and improve processes in the organization

Qualifications and Education

  • We are looking for a colleague who is self-driven and dedicated and who are able to handle many tasks and changing priorities in a busy GMP environment
  • You are flexible, open for changes, and interested in developing yourself into new business areas within the team
  • Almost all tasks require buy-in from stakeholders so you possess excellent communication and collaboration skills
  • You have experience with instrument qualification or maintenance, data integrity and with working in a support function
  • IT flair and/or experience is a benefit, but not a requirement
  • You have a few years of experience with cGMP and pharmaceutical manufacturing
  • Your educational background is Lab technician or an academic degree within life science or IT
  • Fluency in English is required as we are an international company

Your application
If you find the job interesting and it fits your qualifications, please upload your CV and cover letter as soon as possible as we will process the applications as they arrive. For questions please reach out to QC Instruments Supervisor Stephan Spence +45 72141776

 

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We offer

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

Working at FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA.

We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout.

Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.


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