Quality Associate for Drug Substance, Downstream

Job title: Quality Associate for Drug Substance, Downstream

Company: Fujifilm


Job description: Are you ready to play a key role in developing life-saving medicines? Do you excel in quality assurance and thrive in challenging environments?Then we hope you’re our new colleague!Your New RoleYou will be pivotal in ensuring seamless operations and high-quality standards. As you collaborate with stakeholders, you’ll focus on tasks such as campaign changeovers and preparing equipment for transitions between products.Main Tasks

• Review and approval of (in close collaboration with stakeholders)
• Batch records
• Deviations, CAPAs, change controls
• Various document updates, e.g. procedures/work instructions
• Documentation related to automation and our equipment (maintenance, modifications, and alarms-handling etc.)
• Risk assessments

Skills & Knowledge

• + 3 yrs experience in Good Documentation Practice, GMP, quality systems and legislation
• a university degree in a scientific field such as Biotechnology, Pharmacy, Medicine, Chemistry, Biology or similar.

We hope you areA detail-oriented team player thriving in a changing environment who sees the bigger picture and envisions change.Your New Team & DepartmentOur department is experiencing growth and currently consists of approximately 50 people. We put teams over hierarchy by structuring the department into Upstream-, Downstream- and Validation-teams 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!Our international and informal environment maintains a high pace and focus on life balance while fostering fun and engagement.ApplicationHas this sparked your interest? Then please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis.If you have any questions, please do not hesitate to reach out to our Associate Managers: Esben Nisted atbefore 01JUL25, contact Harald Olsen at due to vacation.FUJIFILM 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 hereFUJIFILM Biotechnologies Denmark 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.

Expected salary:

Location: Hillerød, Hovedstaden

Job date: Sun, 29 Jun 2025 05:32:22 GMT

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