Senior Quality Assurance Associate
Grade – 32
Post Ref – QA/0039
Salary – £28,409 – 35,512
Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing manufacturing processes for customers biologic drugs and offering stability studies to support customer drug substance and drug products.
With plants in Billingham, UK, North Carolina, USA and Texas USA our global vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.
As we continue on a period of significant growth we have an opportunity for Senior QA Associate in the Quality Assurance Microbial Manufacturing Group.
The candidate will be responsible for the following:
- To act as the QA Representative on Business Programmes, involved in the manufacture of biological Bulk Drug Substance (BDS) and cell banks used in clinical trials and commercial product.
- Build and maintain good working relationships with Manufacturing. Working with manufacturing personnel to improve compliance and feedback learning.
- QA assessment of events / minor deviations
- QA review of Manufacturing Records
- Plant Inspection
- Co-ordinate batch disposition activities
In order to fulfil this role the candidate must be flexible, self-motivated and have the ability to work as part of team. They will need to be able to build strong relationships with a wide variety of individuals. This role requires an individual with proven knowledge of cGMP, the ability to provide a critical assessment of data, good decision making skills, effective communication skills and influencing skills to convey compliance based decisions. A scientific qualification would be preferable.
We offer a generous benefits package including;
- Competitive salary plus company bonus scheme
- Up to 35 days of holiday, plus bank holidays.
- Salary Sacrifice scheme offering childcare vouchers, bikes, dental etc.
- Free parking.
- Generous pension scheme
For further information please see attached Job Description and Person Specification.
Interested applicants must complete an application form and send to HR no later than 12 noon on Friday 23rd November 2018. firstname.lastname@example.org
If we have not contacted you within four weeks of the closing date, please assume that you have not been shortlisted on this occasion.