Quality Control Associate for QC Sample Control

With this position as QC Associate, we offer an opportunity to be part of our QC Sample Control team in FUJIFILM Biotechnologies on our site in Hillerød. Our new colleague will be responsible for picking up samples in our Drug Substance Manufacturing area, aliqout samples aseptically, perform functionality testing of pens, prepare Drug Substance and Drug Product release samples for the labs, setting up shipments for QC samples going to our customers and contract laboratories, generating QC CoA´s and other related tasks. The team is covering support to Manufacturing 365 days a year, hence working hours includes weekend work on day shift every 4th weekend as well as on holidays. 
The job is an exciting combination of handling both Drug Substance Samples and Drug Product Samples which give a wide range of tasks in the daily work.  

About the Department 

In QC at FUJIFILM Biotechnologies we are 260+ 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 four supporting teams in QC, Sample Control is one of them. 

The QC Sample Control team is closely connected to our production departments as you will be collecting the samples in the manufacturing area and working closely with our QC testing departments for samples to be tested. The work tasks include coordination, collaboration and communication and presupposes a strong GMP mindset. 

In the QC Sample Control team you will have engaged and hard-working colleagues, and a success criteria for filling this position is a can-do attitude, desire to take responsibility and ownership and eagerness to solve a broad range of tasks. The position is a mix of routine and ad hoc challenges, and we work in an ever-changing 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 Biotechnologies is a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently approximately 2000 employees working with every aspect of biotech and pharmaceutical production. 

About the Position 

• Pickup of Drug Substance Samples incl. login to LabWare LIMS 

• Aliquot and deliver samples for QC testing  

• Functionality testing of Pens 

• Receipt of Drug Product Samples incl. login to LabWare LIMS 

• Storage and Inspection of Reference Samples (annual count/inspection) 

• Prepare shipping documents and QC Samples for testing at CLO 

• Generation of CoAs and other data summary reports  

• Creation and maintaining GMP documents in collaboration with stakeholders and QA 

• Cleaning of Equipment 

Qualifications