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Quality Control Associate for QC Sample Control
2 weeks ago
Quality Control Associate for QC Sample Control
Quality Control Associate for QC Sample ControlApply locations Hillerod time type Full time posted on Posted 4 Days Ago job requisition id JR4099
About the Job
With this position as QC Associate, we offer an opportunity to be part of our QC Sample Control team in Fujifilm Diosynth Biotechnologies on our site in Hillerød. Our new colleague will be responsible for picking up samples in our Drug Substance Manufacturing area, aliquot samples aseptically, perform functionality testing of pens, prepare Drug Substance and Drug Product release samples for the labs, set up shipments for QC samples going to our customers and contract laboratories, generating QC CoAs and other related tasks. The team supports Manufacturing 365 days a year, hence working hours include 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, providing a wide range of tasks in daily work.
About the Department
In QC at FUJIFILM Diosynth Biotechnologies (FDB), we are 280+ 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 several 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, requiring a strong GMP mindset.
In the QC Sample Control team, you will have engaged and hard-working colleagues. A success criterion for filling this position is a can-do attitude, a 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". 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 1700+ employees working with every aspect of biotech and pharmaceutical production.
About the Position
- Pickup of Drug Substance /Drug Product 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
- 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
- Assist in QC Sample Control projects
- Participate in cross-functional meetings
Qualifications and Education
- We are looking for a colleague who is flexible, self-driven, energetic, dedicated and open to changes and challenges.
- You are interested in making good working relations with your colleagues, ensuring high productivity and a good working environment.
- You have experience with QC sampling from a pharmaceutical company, preferably both sample handling and aseptic aliquoting.
- You have a strong GMP mindset and a minimum of 2+ 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 and Veeva.
- Your educational background is process operator, lab technician, pharmaconomist or other relevant education.
- Fluency in English is required as we are an international company.
- Flexibility in relation to duties and working hours.
At FUJIFILM Diosynth Biotechnologies, we care about developing our employees. When you start working with us, you are not just starting a new job, but kick-starting your career. As an 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 as we will process the applications as they arrive. For questions, please reach out to Manager Mette Norborg +45 77416306.
Employment Category
You will work mainly on a day shift, including work on weekends and holidays as we support manufacturing 365 days a year. Normally we have team members to support manufacturing from 06:00 to 15:00 on workdays. We are focused on setting up a work schedule that balances work and life, hence we aim to ensure only work one weekend every 4th week.
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 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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.
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