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Lead Quality Assurance Specialist

2 months ago

St Albans, Hertfordshire, United Kingdom Baxter Full time

Join Our Team: Senior Quality Assurance Associate

About Baxter: Baxter is a leading global healthcare company committed to enhancing patient outcomes through innovative medical solutions. With a rich history of over 85 years, we are at the forefront of advancements in healthcare. Our dedicated team in Elstree, UK, specializes in the production of critical medical products.

Position Overview:

  • Assist in the review process of production batches
  • Authorize the release of raw materials and components for manufacturing
  • Compile data related to the release of finished goods
  • Ensure all deviations are resolved before product release
  • Oversee document management processes
  • Facilitate quality investigations
  • Engage in internal and supplier audits
  • Support inspections by regulatory bodies
  • Manage statistical process controls
  • Contribute to cross-departmental project teams

Qualifications:

  • Bachelor's degree in a scientific, technical, or engineering discipline is preferred
  • A minimum of 2 years of experience in a Good Manufacturing Practice (GMP) setting
  • Familiarity with ISO13485, FDA regulations, and GMP practices
  • Experience working in cleanroom and sterile manufacturing environments
  • Excellent communication abilities