Quality Control Associate for QC Lab Support

Hillerød, Denmark

Are you a highly experienced GMP supporter used to working with deviations, change controls and documentation in QC? Does your CV include experience with CLO management or CDMO work?
Can you handle many tasks and changing priorities in a busy GMP environment without losing your good mood? Are you known to be a good coordinator, a skilled communicator and an experienced collaborator who your stakeholders enjoys working with? Do you have an eye for optimizations and improvements, and can you drive great solutions to implementation? And finally, 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 and quality to our customers and colleagues and enjoys each other’s company? 

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 onsite manufacturing processes as well as stability samples. We have a number of testing teams and five supporting teams in QC, Lab Support is one of them.

The core tasks in QC Lab Support evolves around GMP compliance and includes a number of challenging and fun tasks such as; managing QC change controls both for internal changes and changes coming from our customers, driving QC investigations and CAPA´s and management of the contract laboratories (CLO´s) we use for drug substance, drug product and raw material testing.

We are also responsible for forecasting and planning of QC testing and release activities, data entry approval, quality data generation for metrics and review meetings, management of controls and reference standards and ownership of specifications. Furthermore, we have some customer contact responsibilities and we deliver support for internal audits and inspections as well as other support to the rest of the QC organisation and other departments on site.

We are looking for a new colleague who can be part of our team, and in this particular role have special focus on the change control, investigation and documentation part as well as CLO management and customer contact tasks.

 

FUJIFILM Diosynth Biotechnologies (FDB) is a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently approximately 750 employees working with every aspect of biotech and pharmaceutical production.

About the position

Drive and coordinate QC change controls for both internal and external changes together with relevant stakeholders, incl. communication with customers as applicable

  • Facilitate QC deviations together with relevant subject matter experts inside and outside QC
  • Create and maintain GMP documents in collaboration with stakeholders and QA
  • CLO management responsibilities including review of quality agreements, contracts, performance KPI data and participate in review meetings as applicable
  • Identify optimization potential and drive implementation of improved processes including document updates and other relevant tasks
  • Initiate deviations and support investigations as applicable
  • An element of new tasks that will follow our site expansion the next years

Qualifications and Education

  • You have  several years of experience with cGMP and pharmaceutical manufacturing
  • You are highly experienced in handling GMP deviations, change controls and documentation
  • You have worked with CLO management and have experience working as an CMO/CDMO
  • You have an academic degree or other similar education
  • On a personal level you are self-driven and dedicated, systematic and able to improve processes while working with the current systems
  • You are flexible and 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 might have experience with QC data systems such as LIMS and SmartQC or metrics tools such as Tableau
  • Fluency in English is required as we are an international company

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 Lab Support 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 as we will process the applications as they arrive. For questions please reach out to QC Supporting Teams Manager Henriette Hørbov +45 7741 6542.


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