Quality Control Associate for QC Sample Control
FUJIFILM Diosynth Biotechnologies
Dato: for 2 dage siden
By: Hillerød
Kontrakttype: Fuldtid
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, 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 Diosynth Biotechnologies (FDB) 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 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
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 in 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 focussed on setting up a work schedule that balances work and life, hence we aim to ensure weekend work only occurs 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 fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
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. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid
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, 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 Diosynth Biotechnologies (FDB) 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 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 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
- We are looking for a colleague who is flexible, 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 sample handling and aseptic aliquoting.
- You have a strong GMP mindset and minimum 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.
- 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.
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 in 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 focussed on setting up a work schedule that balances work and life, hence we aim to ensure weekend work only occurs 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 fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
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. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid
Sådan ansøger du
For at ansøge om dette job skal du autoriseres på vores hjemmeside. Hvis du endnu ikke har en konto, bedes du registrere dig.
Opslå et CVLignende jobs
Servicetekniker
SSI Diagnostica Group,
Hillerød
for 3 dage siden
Kunne du tænke dig at blive en del af en virksomhed i rivende udvikling? Har du et udpræget servicegen i kombination med en solid teknisk erfaring? Kan du lide at arbejde med produktionsanlæg og utilityudstyr? – og forstår hvor vigtigt vedligehold heraf er? Og har du lyst til at give dit bidrag til SSI Diagnosticas fortsatte insisteren på at levere...
Scientist for QC Tech Transfer & Sample Support Team (Maternity Cover 12 months)
FUJIFILM Diosynth Biotechnologies,
Hillerød
for 4 dage siden
Join Our Mission to Make a Global Impact in Pharmaceuticals!This position is a maternity cover with the potential for a permanent role.Are you ready to take on a proactive role that not only challenges you but also allows you to make a significant difference in people’s lives around the world? At our company, we strive to empower our team members...
Intern Drug Substance Manufacturing
FUJIFILM Diosynth Biotechnologies,
Hillerød
for 2 uger siden
FUJIFILM Diosynth Biotechnologies is undergoing rapid development, our company is expanding at high speed, and this is just the beginning. It is therefore important that we continuously optimize our processes and quality, to ensure that we can keep up with this development. We are looking for people who share our passion, drive, and energy to be part of our Continuous...