Senior QA Associate

☞ FUJIFILM Diosynth Biotechnologies

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Update day: 07-05-2024

Location: Billingham Yorkshire and the Humber

Category: Pharmaceutical / Chemical / Biotech

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FUJIFILM Diosynth Biotechnologies :
We are different. We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life, you change others’ too.

We are looking for people who share our passion, drive, and energy – what we call Genki. Join us and commit your life’s work to impacting where it matters most: human lives.

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.


We are growing and we are growing fast. 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:
  • Ensure all manufacturing operations work undertaken is performed in accordance with cGMP quality system.
  • To act as the Quality Representative on cell bank programmes used in clinical trials and commercial product.
  • Acting as the main customer interface for Quality related aspects of a programme.
  • Co-ordinate the Quality activities of a programme from the GMP preparation phase through manufacturing support to batch disposition.
  • Identify concerns with processes, batch documentation or data and where possible develop and contribute to the development of solutions with management support.
  • Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self and any direct reports.
  • Demonstrate sound knowledge and understanding of scientific principles, Quality systems and regulatory expectations.
  • Provide QA support to the QC and manufacturing teams.
  • Assist the QA Associate Manager / Quality Project Manager in planning processes, to ensure that programme deliverables are achieved according to procedures and within the timelines contractually agreed.
Qualifications and Experience:
  • Science Degree or equivalent experience - Desirable
  • Maths, English & Science GCSE Level C or above - Essential
  • At least 2 years working in a GMP environment. - Desirable
  • Knowledge of QA systems: (for example Events/Deviations, CAPA’s, change control) - Essential.
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 on-going development training. In addition to this, we offer:
  • Competitive salary plus company bonus scheme
  • Up to 35 days of holiday, plus bank holidays.
  • Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
  • Generous pension scheme
  • Free parking
Closing date 27 July 2021.

Senior Quality Assurance Associate (Manufacturing Operations PS
Senior Quality Assurance Associate (Manufacturing Operations) JD
Why Work in Billingham
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Deadline: 21-06-2024

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