Experienced Quality Associate for Drug Substance Upstream

Are you ready to be an important part of development and assurance of quality for the next vaccine, life-saving cure, or revolutionary gene therapy?

At FUJIFILM Diosynth Biotechnologies, an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Here you will have the chance to learn from some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact in people’s lives.

About the Role and your qualifications
The Drug Substance QA Upstream team is seeking an individual with experience in Good Documentation Practice, GMP, quality systems and legislation, who holds a university degree in a scientific field such as Biotechnology, Pharmacy, Medicine, Chemistry, Biology or similar.

Our team takes care of a variety of tasks, including but not limited to the below.

Review and approval of (in close collaboration with stakeholders):

• Batch records
• Documentation related to automation and our equipment (maintenance, modifications, validation, and alarms-handling etc.)
• Campaign changeovers, getting the equipment ready between one product and another
• Various document updates, e.g. procedures/work instructions
• Incidents, CAPA’s, change controls
• Risk assessments

In the above, we highly encourage exhibiting GEMBA (go see) when collaborating with our stakeholders, to better understand the issues and foster better discussions cross-functionally.

Additionally, we offer the opportunity to be the QA partner when bringing in new products from existing or new customers (tech transfer).

About the Department
As a valued member of the DS QA Department, you will thrive in this role if you enjoy a changing environment in collaboration with great colleagues and stakeholders engaging in activities spanning manufacturing operations and optimizing projects.

Our department is experiencing robust growth and currently consist of approximately 40 people. We put teams over hierarchy by structuring the department into Upstream-, Downstream- and QP-team where daily interactions and support foster professional and personal development across the teams.

We encourage you to bring your full self to work every day, as we value everyone’s unique talents and strengths. So just be you!

Application

Has this sparked your interest?
Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis.

Should you have any questions, please feel free to reach out to Manager in DS QA Upstream, Alexander Overby ([email protected]).

The Company
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.

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 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