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Quality Assurance QA Specialist

Job Title: Quality Assurance QA Specialist
Contract Type: Contract
Location: Manchester, Greater Manchester
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: J893470_1517575000
Contact Name: James Lowe
Contact Email: James.Lowe@russell-taylor.co.uk
Job Published: February 02, 2018 12:36

Job Description

Role: QA Quality Assurance Specialist 12 month's contract

Location: Manchester, UK

Salary: Competitive

Russell Taylor Group has a fantastic opportunity to join a Global Medical Device company who are ever growing and looking to recruit an experienced QA Quality Assurance Specialist to work at their modern facility in Manchester. The successful Candidate will be rewarded with furthered training in a highly regulated environment and play a key role in the internal auditing, QMS, validation of equipment, CAPA investigations, Document Management, quality audits and other laboratory duties. This is an excellent opportunity to gain valuable experience within a global ISO 13485 / Medical Device Company.

Role:

  • Independently developing the quality system & making recommendations to management regarding continuous quality improvement of the existing quality system
  • Responsible for Quality Management as defined by ISO 17025:2005(E) and GCP with responsibility and authority for ensuring that the management system related to quality is implemented and followed at all times
  • Developing, collecting, analysing & presenting departmental metrics, trends, & suggesting corrective actions
  • Conducting compliance audits of extremely complex documentation & data
  • Leading internal, external, customer and regulatory body audits of Biomarker Services and in the external audit of suppliers
  • Interfacing with other departments, customers & Regulatory Bodies to drive implementation of Quality System changes for new processes & technology
  • Administering and provide technical support for QA software such as Q-Pulse/Agile for, Audit, CAPA, and OOS investigations
  • Reviewing and assessing the appropriateness of document changes in accordance with internal procedures for extremely complex processes
  • Reviewing & assessing change control, validation & qualification documents
  • Identifying Quality System Gaps and developing processes to mitigate
  • Chairing quarterly and monthly quality meetings
  • Authorised Document Controller
  • Lead management reviews of the quality system
  • Maintain the archive of Biomarker Services client reports at the Manchester site

Person:

  • Bachelor's degree or equivalent degree required
  • The required skills, knowledge and abilities are typically acquired through a working experience in the contract research or pharmaceutical industries
  • Excellent command of English language and grammar and demonstrated proficiency in written and oral communications
  • Computer literate in Windows, word processing, spreadsheets, Internet and databases
  • Must be able to work effectively within technical groups involving many disciplines
  • Must demonstrate initiative, balanced assertiveness and working as a team player