QA Associate - Pharmaceutical

SLS Services Limited
Bishop's Stortford
05 Feb 2017
05 Mar 2017
Contract Type
Full Time
- QA Associate
- Bishops Stortford, Hertfordshire
- Innovative Pharmaceutical organisation
- Salary around £25,000 + benefits
- Broad Quality Assurance position, ensuring compliance to GMP, ISO9001, HTA & HFEA regulations
- Excellent career development opportunities

Do you have experience from a Quality-focused role in a GMP or ISO environment? If so, this could be an excellent career opportunity. A brand new role has been created with a leading biobank and bioservices organisation in Bishop’s Stortford. We are looking for a person with some QA experience gained within a GMP or ISO 9001 environment. You will undertake a range of QA activities supporting the implementation of quality systems and ensuring regulatory and Quality Management System compliances. An excellent opportunity to develop basic skills and experienced backed by training and support.  

The Company
One of the most reputable and successful providers of biological storage and bioanalysis services to Pharmaceutical organisations running clinical trials. Based near to Bishop’s Stortford the site has around 50 staff within a state-of-the-art, GMP-regulated facility. The services they offer include laboratory kit assembly, packaging, labelling and distribution, plus sample collection, sample storage and sample analysis. The site has different repository areas, some of which are ambient while others are cold or freezing (one liquid nitrogen cryogenic room is minus 30 degrees Celsius). 

The Role
As a Quality Assurance Associate you will undertake a a range of QA activities supporting the implementation of quality systems and ensuring regulatory cGMP / ISO 9001 and Quality Management System (QMS) compliance's Your responsibilities will include the following: 

- SOP review and management
- Review of draft operational documentation
- Assure compliance to ISO9001, GMP, MHRA, HTA and MFEA regulations
- Perform Quality Review of change controls
- Participate in deviation investigations
- Check operational documents for completeness, accuracy and adherence to Good Documentation Practice

You will join a supportive QA team within a company that has a reputation for its training programmes, development support and positive working environment. 

In addition to a competitive salary a comprehensive benefits package is on offer including private health care, bonus and pension scheme.

The successful candidate will have previous experience in a regulated clean room / GMP / ISO setting preferably pharmaceutical related. You must have a background in QA activities, including updating SOPs, compiling and writing reports, processing data and communicating in a positive way with people across different teams. 

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This is a permanent role