Quality Control Associate for QC Supporting Function

About the job

Are you able to handle many tasks and changing priorities in a busy GMP environment? Are you focused on optimizations and improvements, and can you drive great solutions to implementation? Are you a good coordinator, a skilled communicator and an experienced collaborator that your stakeholders enjoy working with? 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?

About the department

In QC at FUJIFILM Diosynth Biotechnologies 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 onsite manufacturing processes as well as stability samples. We have a number of testing teams and two supporting teams in QC, Sample Control is one of them.

In QC Sample Control we have multiple different business areas supporting the rest of QC and our customers. We work cross functionally and have stakeholders from many departments on site.

Our primary tasks are ensuring that samples and information are received from production (on site and off-site) and distributed to testing labs, that data are retrieved, reviewed and shared with our customers and that the supporting documentation is in place. We are responsible for stability samples, testing specifications, reference standard and retain sample inventory and a number of other interesting tasks. And we are looking for a colleague who can be part of this, and in this particular position also be responsible for internal QC planning.

About the position

  • Be part of our QC Planning unit, responsible for coordinating and communicating testing plans from customers to testing labs and for maintaining our forecasting tool
  • Responsible for data entry approval processes
  • Identify optimization potential and drive implementation of improved processes
  • Participate in daily tasks such as data generation, alarm handling, sample handout etc.
  • Create and maintain GMP documents in collaboration with stakeholders and QA
  • Initiate deviations and support investigations as applicable 

Qualifications and Education

  • You are experienced with QC data systems and QC planning tools preferably LIMS and SmartQC
  • You have min 2+ years of experience with cGMP and pharmaceutical manufacturing
  • Your educational background is Lab technician or an academic degree or other relevant education
  • Fluency in English is required as we are an international company

We are looking for a colleague who is self-driven and dedicated, who is systematic and able to improve processes while working with the current systems. Furthermore you:

  • Are flexible and open for changes and interested in developing yourself into new business areas within the team
  • Possess excellent communication and collaboration skills as almost all tasks require buy-in from stakeholders so you

At FUJIFILM Diosynth Biotechnologies we care about developing our employees so when you start working with us, you are not just starting a new job, but kick starting your career. As employee in QC Sample Control we provide you with a variety of development options in a busy and changing environment.

Your application
If you find the job interesting and it fits your qualifications, please upload your CV and cover letter as soon as possible and latest by the 16th of February. We will process the applications as they arrive. For questions please reach out to QC Sample Control Manager Henriette Hørbov +45 77416542.

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