Senior QA for QC specialist
FUJIFILM Diosynth Biotechnologies
Dato: for 1 uge siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Entreprenør
Join our QA for QC Team at FUJIFILM Diosynth Biotechnologies in Hillerød and work as QA specialist supporting our QC laboratory. As our production site grows, QC expands which requires more Quality Oversight.
We are looking for the right senior QA specialist who would like to be part of a positive, engaged and supporting team.
Your New Role
As senior QA for QC specialist, you are the main QA contact for the QC laboratory in all their activities. You will have the responsibility of reviewing and approving QC relevant documents (test method documentation, instrument qualifications etc), equipment alarms, changes and deviations.
Furthermore, you will engage proactively with QC to enhance compliance and secure quality oversight support in general.
Primary Responsibilities
a self-driven team-player thriving by building the road as we go and with excellent skills and eminent structure skills.
Skills & Knowledge, We Hope You Possess
The right mindset, strong deliverables and practical experience is key. Educational background comes second, but could be within the following areas (though not prerequisite)
Currently the team consists of 8 persons and is part of a QA department also overseeing the quality of Raw Materials & Supply Chain – and further part of a larger QA organization which provides quality support to production of batches in drug substance manufacturing, filling of drug product and Assembly, Label and Pack. QA for QC is a dynamic team that has close collaboration with multiple internal stakeholders and QA colleagues.
The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.
Your application
Has this sparked your interest? Then please upload your CV and cover letter as soon as possible as we conduct interviews on an ongoing basis and will take down the advert when we have found the right candidate.
If you do not match all of the above-mentioned criteria, but believe you have something to contribute with and still find the position interesting, then please send your application.
FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/
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.
We are looking for the right senior QA specialist who would like to be part of a positive, engaged and supporting team.
Your New Role
As senior QA for QC specialist, you are the main QA contact for the QC laboratory in all their activities. You will have the responsibility of reviewing and approving QC relevant documents (test method documentation, instrument qualifications etc), equipment alarms, changes and deviations.
Furthermore, you will engage proactively with QC to enhance compliance and secure quality oversight support in general.
Primary Responsibilities
- Perform QA support to QC; Review and approve QC related documentation.
- Assess and approve changes and deviations related to QC activities.
- Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported. Act as quality partner by providing guidance, training and ad hoc support to stakeholders herewith.
- Represent QA for QC on assigned projects related to QC.
- Take part in local and potential future global alignment tasks within QA for QC.
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications.
a self-driven team-player thriving by building the road as we go and with excellent skills and eminent structure skills.
Skills & Knowledge, We Hope You Possess
The right mindset, strong deliverables and practical experience is key. Educational background comes second, but could be within the following areas (though not prerequisite)
- Bachelor or Master of Science in natural science, e.g. Pharmacy, Biotechnology, Biology, Engineering or similar.
- Well-versed in GxP guidance and knowledge of quality systems
- 3+ years of work experience or educational background that allows for understanding of the complexity of manufacturing biologics.
- Preferably experience with overseeing quality of method transfers.
- Speak and write English fluently
Currently the team consists of 8 persons and is part of a QA department also overseeing the quality of Raw Materials & Supply Chain – and further part of a larger QA organization which provides quality support to production of batches in drug substance manufacturing, filling of drug product and Assembly, Label and Pack. QA for QC is a dynamic team that has close collaboration with multiple internal stakeholders and QA colleagues.
The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.
Your application
Has this sparked your interest? Then please upload your CV and cover letter as soon as possible as we conduct interviews on an ongoing basis and will take down the advert when we have found the right candidate.
If you do not match all of the above-mentioned criteria, but believe you have something to contribute with and still find the position interesting, then please send your application.
FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us—your drive meets boundless opportunity here https://fujifilmdiosynth.com/
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.
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