Senior QA for QC specialist

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.

The QA for QC team currently consists of 11 persons and is 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.

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, Raw Material Specifications, 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 (and potential impact to our customers).
• 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.

Qualifications / Skills

• Collaborative mindset with a willingness to integrate oneself in the team and organisation
• Well-versed in GxP guidance and knowledge of quality systems
• Ability to work in a very dynamic environment and thrive building the road as we go.
• Self-driven, proactive and excellent communication skills and good at creating structure
• 3+ years of work experience or educational background that allows for understanding of the complexity of manufacturing biologics
• Speak and write English fluently

Education
The right mindset, strong deliverables and practical experience is key. Educational background comes second, but could be wihin the following areas (thought not prerequisite); Bachelor or Master of Science in natural science, e.g. Pharmacy, Biotechnology, Biology, Engineering or similar.

If you do not match all of the above mentioned criterias, but believe you have something to contribute with and still find the position interesting, then please send your apply.

Application
Has this sparked your interest? Then we urge you to apply with your CV and cover letter as soon as possible as we will be interviewing on an ongoing basis. We will take down the advert when the right candidate has been identified.

About FUJIFILM Diosynth Biotechnologies
We are 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.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. 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. Learn more at https://fujifilmdiosynth.com/

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, 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.

Location: FDBD Hillerod