Senior Quality Assurance Associate

at  Fujifilm Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies :
Fujifilm Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. This biomanufacturing facility will provide additional Cell Culture and Viral Gene Therapy cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025.
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:

Initially the job role will be acting as QA on the implementation of the new manufacturing facility, working on implementing new systems, processes and procedures, once the manufacturing facility is live and operational it will be transitioning to a business as usual role proving QA oversite on the manufacture of GMP products to ensure compliance throughout the process life cycle.

• Knowledgably 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.
• Evaluation of data with recommendations for decision making made to QA Management.
• Identification and assessment of risk with appropriate escalation.
• To act as Quality Representative including verbal and written communication in customer program/project meetings.
• Operate core QA events and minor deviations.
• Document writing and review processes as instructed by QA Management.
• Ensure self has no overdue training, or site actions.
• Train staff in own and other areas as required in specific tasks related to job role

Qualifications and Experience:

• Science Degree or equivalent experience
• Maths, English & Science GCSE Level C or above
• At least 2 years working in a GMP environment.
• Knowledge of QA systems: (for example Events/Deviations, CAPA’s, change control)
• Experience managing small change projects or Yellow Belt
• Proven ability to problem solve and make decisions

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
• 35 days of holiday, plus bank holidays.
• Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
• Generous pension scheme
• Free parking and electric charging points

• Knowledgably 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.
• Evaluation of data with recommendations for decision making made to QA Management.
• Identification and assessment of risk with appropriate escalation.
• To act as Quality Representative including verbal and written communication in customer program/project meetings.
• Operate core QA events and minor deviations.
• Document writing and review processes as instructed by QA Management.
• Ensure self has no overdue training, or site actions.
• Train staff in own and other areas as required in specific tasks related to job rol