Quality Associate - Oxford

  • Job Reference: H481
  • Date Posted: 25 January 2018
  • Location: Oxford UK
  • Salary: £30,000
  • Sector: Biology / Pharma
  • Job Type: Permanent
  • Work Hours: Full Time
  • Contact: Consultants
  • Email: info@harringtonrecruitment.com
  • Telephone: 0208 349 8112

Job Description

Key responsibilities:

  • Assistance with running the Quality Management System (QMS)
  • Assistance with management of health and safety provisions
  • Activities related to the Human Tissue Management System (HTMS)
  • Helping to develop the Management System so that it is compliant with the requirements of statutory bodies such as the HSE, HTA and MHRA
  • Assistance with preparations for external audit by competent authorities and notified bodies to maintain licences and certifications
  • Managing the archiving of paper records relating to the QMS
  • Assistance with the collection of data for monitoring key performance indicators in the business which will be reported to management review every 6 months
  • Assistance with the investigation of the root causes of incidents or issues that arise within the business
  • Assistance with maintenance of the Improvements Database and chasing up of corrective actions to drive continual improvement within the company
  • Working with the Quality Manager to achieve quality objectives set by the senior management team
  • Issuance and indexing of batch records for manufacturing and quality control activities
  • Maintenance of the company intranet

The successful candidates will have the following responsibilities and training will be provided:

  • Assistance with running the Quality Management System including Health & Safety management and Human Tissue management.
  • Maintenance of management system compliance with the requirements of statutory bodies.
  • Assistance with preparations for external audits by competent authorities and notified bodies such as the HSE, HTA, BSI, and MHRA.
  • Performance of internal audits (training will be provided).
  • Managing and archiving of paper and electronic records relating to the QMS.
  • Collection and analysis of data for management review.
  • Investigation of root causes of incidents or issues that arise within the business.
  • Working with the Quality Manager to achieve quality objectives set by the senior management team.
  • Maintenance of the QMS via the company intranet.

Skills & Experience:

  • BSc in a life sciences or relevant experience
  • Experience in quality management
  • Knowledge of medical devices, ISO requirements, compliance, CAPA or auditing would be advantageous
  • Good communication skills and computer literacy
  • Attention to detail
  • Team player
  • Prior experience in a genetics/molecular biology laboratory would be advantageous

Essential

  • Previous experience of working in a laboratory environment
  • Strong written and verbal communication skills

Desirable:

  • Good knowledge of Microsoft Office including Visio and Access
  • Experience of working in a quality assurance or health & safety management role