Senior QA Specialist

As a QA specialist, come and join our QA FG Partner support team supporting Finished Goods Manufacturing (FGM) at FUJIFILM Diosynth Biotechnologies in Hillerød. We are handling Material release, Customer initiated Changes, Master data approval, Product and Supplier Complaints, Quality Oversight of Supply Chain, Deviations, APQR and we are also supporting projects and Tech transfers of new products into the facility.

We are looking for the right senior QA specialist who would like to be part of a positive, engaged and supporting team.

About the Department/Team

QA Finished Goods department at FUJIFILM Diosynth Biotechnologies in Hillerød consists of 22 employees, covering all QA activities related to Finished Goods Manufacturing. QA FG Partner Support is one team out of two sister teams.

You will be part of the QA FG Partner Support team consisting of 8 dedicated employees.

We support the processes prior to and post manufacturing. We support each other in the daily routine tasks as well as projects to be executed - all done through very open and honest communication within the team and in very close collaboration with our colleagues in FGM and supporting functions. The work environment is informal, where we strive to have fun, while we support the daily operations and the ongoing projects making sure that results are delivered within the dedicated timelines. We take pride in working with all types of stakeholders on all levels of the organization.

About the Role

As a Senior QA Specialist you will have the responsibility of releasing Material for Finished Goods Manufacturing, QA review and approval of Master Data, Initiation and approval of Specifications, internal and external change management, deviations and Event trending, handling of product and supplier complaints. Furthermore, you will support quality oversight of Supply Chain, including both internal and external Warehouses. You will engage proactively with relevant stakeholders to enhance compliance and secure quality oversight support in general. You will have a close collaboration with many different stakeholders in both FGM and supporting functions as well as other QA functions to ensure flexibility and to align our Quality mindset for the site.

Additionally, in this role you will also be involved in projects e.g Tech transfers of new products into our facility.

Having an informal work environment, strive to have a lot of fun, being a team player, keeping calm during periods with competing priorities are highly valued attributes for this role.

Your primary tasks will be:

• Perform QA release of Materials for use in manufacturing.
• Provide QA support to our testing team for incoming materials. Review and approve related documentation and material specifications.
• Handle customer-initiated changes, including review and approval of Master data in SAP, maintain product specifications, review and approval of related documentation.
• Assess and approve internal and external changes and deviations related to both FGM and Supply Chain activities including assessment of potential impact to our customers.
• Handle product and supplier complaints.
• Perform Event trending and pull data for QMR and APQR reporting.
• Act as quality partner by providing guidance, training and ad hoc support to stakeholders.
• Represent QA on assigned projects related to FGM and Supply Chain including tech transfers of new products.
• Support continuous improvements related to QA processes.
• Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines and policies.

Qualifications / Skills

• Bachelor's or Master's of Science in natural sciences, e.g., Pharmacy, Biotechnology, Biology, veterinary science, pharmaceutical chemistry and technology, chemistry, biology or similar.
• +2 years of experience with GMP and experience from QA and/or manufacturing experience from the pharmaceutical industry.
• Speak and write English fluently.

Personal qualifications

You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders. You have a positive and pragmatic attitude with focus on delivery times. You take ownership of your work and feel comfortable by independently resolving issues. You have solid interpersonal skills and enjoy cooperating with colleagues from different cultures, on all levels and from different functions with the focus of building a strong collaboration and trust in your network.

You possess excellent communication and collaboration skills – and understand the need for working closely together in your own team but also across teams – helping each other deliver on common goals.

Lastly, if you see yourself as a high performing team player who is ambitious on behalf of yourself and the company, then you might be just the candidate, we are looking for!

Application

Are you interested? 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.

For questions, please reach out to Associate Manager, Quality Assurance Annette Lundsgaard at [email protected] or mobile 42651285

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.

Our site in Hillerød, Denmark, brings together expertise, capabilities, and technologies to manufacture advanced biologics. The large-scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.