FUJIFILM Diosynth Biotechnologies
We are a trusted CDMO partner for life. At FUJIFILM Diosynth Biotechnologies (FDB), we encourage you to discover what inspires you every day, to follow your passion and your power – what we call Genki.
The work we do has the potential to transform people’s lives and to impact where it matters most. Each day is an opportunity to push the boundaries of your potential, so join us as Senior QA or QA Associate and become part of a fast-growing global company, united by Genki.
About Us
We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.
With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.
Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.
Role & Responsibilities
* Administer, maintain, and continuously improve any assigned QA systems, which may include Document Control and Issue, Change Control, Events Deviations & Non Conformances (Trackwise), Root cause analysis, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training.
* Assessment/preparation of data for decision making by QA management.
* Identification of risk and appropriate escalation.
* Operate core QA events.
* Document writing and review processes as instructed by QA Management.
Qualifications and Experience
* At least 2 years working in a GMP environment.
* Science Degree or equivalent experience.
* Knowledge of QA systems (for example, Events/Deviations, CAPA’s, change control).
* Experience managing small change projects.
* Experience with Microsoft Office such as Microsoft Word, Microsoft Excel, and Google Docs.
Why work with us?
At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.
When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as ongoing development training. In addition to this, we offer:
* Competitive salary plus company bonus scheme.
* 35 days of holiday, plus bank holidays.
* Salary Sacrifice scheme offering healthcare, bikes, dental etc.
* Generous pension scheme.
* Free parking and electric charging points.
Closing date: 7th February 2025
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