Quality Officer

Recruitment Genius Ltd
Scotland, North Lanarkshire, Motherwell
£20000 - £25000 per annum
12 Oct 2016
27 Oct 2016
Recruitment Genius Ltd
Contract Type
Full Time
This company was founded on the mission of making personalised medicine a reality by harnessing and making available the therapeutic and regenerative power of their precious stem cells to address the growing need of lifesaving stem cells transplantation.

They are a privately owned company founded in 2008 and engaged in the development of stem cell and personalised medicine technologies. The company has a strong R&D division which houses a multi-patent protected asset pipeline involving the commercialisation of biologics drug discovery, stem cell transfusion medicine applications and biomolecular diagnostics.

They are looking for a QA Officer to join their R&D division and play a key role in supporting the team and ensuring compliance.

Main Job Purpose

Maintain and develop quality systems in place as well as provide support for administrative activities associated with their quality activities.

Key Duties and Responsibilities include:

- Take on leading a role in the administration of the company's electronic Quality Management System
- Participate in incident management including putting in place and reviewing corrective and preventative actions (CAPAs)
- Writing and reviewing controlled documents to ensure compliance with HTA and other relevant regulatory requirements
- Performing data reviews and approving production results
- Supplier and stock management, quality checking consumables against specification, manufacturer documentations and release criteria
- Reviewing and approving suppliers / service providers including audit of critical suppliers where required
- Performing internal and external audits of processes and equipment to determine compliance with ISO9001:2008 as well as other standards in place and identify areas for improvement
- Supporting risk management and reviewing and approving risk assessments
- Delivering training to staff on quality related procedures and policies
- Supporting regulatory authorities/customer audits of the company
- Providing advice and guidance to the team with support from other senior team members
- Ensuring compliance with all health and safety policies and procedures
- Some limited travel, mainly to BioCity Scotland to ensure standards and procedures are implemented as required across all their laboratories.

Essential Skills
- An honours degree in a life sciences subject
- Proven Quality experience within an ISO9001:2008, ISO15189:2012 or GMP environment
- Excellent administrative skills
- Excellent data recording and record keeping skills with a good eye for detail
- Organisational and planning skills with the ability to plan ahead whilst delivering results to deadline

Preferred or Desirable Skills
- A good scientific knowledge of cell therapies, cell culture or cell biology is desirable
- Experience in using Q-Pulse electronic Quality Management System or similar system would be desirable