Quality Control Associate for QC Sampling Team

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Hillerød

About the job

With this position as QC Associate we offer an opportunity to be part of our QC Sampling team in Fujifilm Diosynth Biotechnologies on our site in Hillerød. Our new colleague will be responsible for planning and execution of different sampling activities in our facility as well as be involved in setting up shipments for samples going to our contract laboratories and other related tasks.
The job is an exciting combination of sampling as it includes Environmental Monitoring (EM) in classified areas, Utility Monitoring (UM) of water systems in both classified and non-classified areas of our facility and Raw Material (RM) sampling of the components and consumables used in our Drug Substance Manufacturing.

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 two supporting teams in QC, the sampling team belongs to one of them.

The QC Sampling team is closely connected to our production departments as you will be “walking the grounds in manufacturing” when collecting EM and UM samples, and working closely with our Warehouse department when sampling the raw materials. The work includes walking and talking, coordination and collaboration and you will need energy and physics to handle the raw materials.

In the QC Sampling team you will have five engaged and hard-working colleagues, and a success criteria for filling this position is a can-do attitude, eagerness to solve a broad range of tasks and desire to take responsibility and ownership. The position is a mix of routine and ad hoc challenges and we work in an everchanging world, so the right candidate must thrive within and out of the “comfort zone”. And you are of course a strong team player who also appreciates the social part of being in a team – and a good laugh.

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

  • Sampling of Environmental Monitoring samples in classified areas; microbial and particulates
  • Sampling of Utility Monitoring samples in the Facility; for chemical and microbial analysis
  • Raw Material sampling in classified area; components (chemicals) and consumables (e.g. filters)
  • Setting up shipments for raw material samples going to CLO´s
  • Handling and analysis of EM and UM results, incl. planning and execution of any required additional/investigational samples
  • Trending of EM and UM data
  • Creation and maintaining GMP documents in collaboration with stakeholders and QA
  • Responsible for EM equipment incl. ensuring calibrations and related investigations
  • Work will mostly occur in daily working hours, however, as our production runs 24/7 there might be additional working hours in weekends or out of normal working hours

Qualifications and Education

  • We are looking for a colleague who is self-driven, energetic, dedicated and open for changes and challenges
  • You are interested in making good working relations with your colleagues, both ensuring high productivity and a good working environment
  • You have experience with QC sampling from a pharmaceutical company, preferably both EM/UM and RM sampling
  • You have energy, competencies and physics to work with raw material sampling as it includes handling many units in many sizes
  • You understand the requirements in a bioburden reduced environment/classified areas
  • You have a strong GMP mind set and minimum a couple years of experience with cGMP and pharmaceutical manufacturing
  • You are experienced with QC data systems such as LIMS and pharma related IT systems such as TrackWise
  • Your educational background is EM or process operator, lab technician, pharmacologist or other relevant education
  • 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 Sampling 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 Manager Henriette Hørbov +45 77416542.

Kilde: Jobnet.dk


Information og data

Denne ledige stilling har jobtypen "Smed", og befinder sig i kategorien "Industri, håndværk og teknik".

Arbejdsstedet er beliggende i Hillerød.

Jobbet er oprettet på vores service den 16.4.2020, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Smed
  • Hillerød
  • Torsdag den 14. maj 2020

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