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Process Quality Assurance

Req # JR - 022365 Location Thetford, England, United Kingdom Additional Locations 37.5 Job Category Quality Control Date posted 06/10/2020

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The Process QA will report to the Quality Lead working closely with production to test current products and identify deficiencies against local and global Quality Standards.

Essential Duties and Responsibilities

  • Test current products and identify deficiencies against local and global Quality Standards;
  • Suggest solutions to identified product problems
  • Investigate product quality in order to make improvements to achieve better customer satisfaction
  • Ensure continuous compliance of plant operations to GMP, local procedural requirements and Corporate policies
  • Support the QA team with batch specific investigations and product disposition in order to allow on time batch release
  • Support and lead problem solving investigations for product and process deviations and customer complaints
  • Responsible for investigation and documentation associated with Corrective and Preventive Action
  • Provide coaching to other functions in using problem solving structured approach, investigation tools and CAPA process
  • Collect quality data, identify key KPIs for product quality and prepare and present reports and metrics to management
  • Lead/support Annual Product Quality reviews and other periodic quality management reviews
  • Proactively lead and support Risk Management System activities, risk reduction and continuous improvement initiatives in line with company strategy
  • Perform QA review of CAPA, Change Control and Validation documentation
  • Ensure continuous resourcing and development of the PQA team
  • Ensure timely completion of all Quality System commitments
  • Ensure timely communication of GMP and or product quality issues to QA Management
  • Comply with EHS/GMP/GDP/company and corporate policies and external regulatory requirements


  • At least 3 years experience in Quality Assurance
  • Qualified in a Scientific or Engineering discipline (advantageous not essential)
  • Have excellent inter-personal, organisational and leadership skills
  • Be a passionate advocate of quality as a discipline and continuous improvement
  • Have experience in the use of quality improvement and problem-solving tools, and the interpretation of data
  • Completion of Six Sigma process improvement training (desirable but not essential)
  • Have experience of critical equipment and process Change Control
  • Have experience of critical equipment and process Validation
  • Uncompromising dedication to Quality
  • Personal accountability for results and integrity
  • Relentless focus on rapid and disciplined action
  • Critical thinking and problem solving
  • Strong work ethic

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.

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