Senior QA Associate - Cardiff

Senior QA Associate - Cardiff

Location: Llanishen, Cardiff (CF14) , CF14 View map Salary: competitive, to be negotiated, plus benefits Date posted: 31/05/2012 16:04 Job type:Permanent Company: BBInternational (BBI) Contact: Helen Nutton Ref: Totaljobs/SQA0512DX Job ID: 53689223

Senior QA Associate

SQA0512DX

Competitive

This role is based in Cardiff, working within the BBI Diagnostics, recognised globally for the production of superior quality gold reagents which are used within lateral flow rapid diagnostic tests for the 'Point of Care' (POC) market.

The Person

The Senior QA Associate reports into the QA Manager and has one direct report. They will ensure that all QA activities comply with ISO9001, ISO13485 and FDA Quality System Regulation 21 Part 820 and FDA 21 Part 11. This position will also involve supporting the Head of Quality in other aspects of the BBI Group compliance strategy, and the successful candidate will be a good communicator as there is training and inter-departmental communication responsibilities as part of the role. You will get the opportunity to work on projects and to get involved and put ideas forward, so we are looking for people who want to be part of a team, who are passionate and energetic, and are prepared to challenge themselves and others.

The Role

Main duties include:

To support the BBI Diagnostics and BBI Group annual business objectives

Management of the batch release process ensuring that all products are released in a timely manner

Support BBI Group compliance teams on QA related activities as SME (some travel will be involved)

Mentor and support QA and other departments on best practice (5S, QT&T, LEAN etc.)

Identifying and helping to implement improvement opportunities within the QA department and the business as a whole

Performing activities required for the maintenance of the Quality Management System

Basic Requirements:

Essential

Experience in ISO9001, ISO13485 and FDA CFR 21 Part 820 requirements

Experience in the control of Quality Management Systems

Experienced internal auditor to ISO13485

Experience in GMP requirements

Experience in implementing best practices (5S, Quality tools and Techniques) to a wide group

Desirable

Experience in FDA 21 Part 11 for medical device software

Experience with Integrated Management Systems (QMS, H&SMS, Environment MS)

Six sigma DMAIC training / project experience

The Company

The BBI Group is a hugely exciting business which grew by over 20 in 2011, with a 42m turnover and around 450 people world-wide. At BBI we pride ourselves on our work hard, play hard ethos, and our culture of valuing our individuals has created openings for the BBI team which includes training and professional development, international travel, and the opportunity to do meaningful work on cutting edge products and research.

Other Information

The BBI Benefits package includes the following:

Income protection (75 of salary until retirement)

5 matched pension

Death in Service

Private medical cover

Personal and professional development opportunities

To apply, please email your CV and covering letter to Careers@BritishBiocell.co.uk