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Lead Quality Assurance Specialist

3 months ago

Bristol, Bristol, United Kingdom Bio-Techne Full time

At Bio-Techne, we are dedicated to advancing research in Life Sciences and Clinical Diagnostics. Our commitment to product excellence and customer satisfaction drives our operations while we strive to reduce our environmental footprint. We are seeking a Senior QA Officer to spearhead compliance initiatives across various product categories and operational sectors.

Key Responsibilities:

  • Oversee and direct activities related to CGT manufacturing and weighing timelines
  • Authorize Batch Production Records and Quality Control testing documentation
  • Address non-conformances, deviations, and out-of-specification issues
  • Facilitate and manage CAPA processes
  • Lead documentation oversight and change management
  • Engage in internal and external audit processes
  • Deliver technical support and training initiatives
  • Guide and mentor team members on quality assurance practices
  • Promote a culture of collaboration and high performance

Qualifications:

Essential Education and Experience:

  • BSc/BA degree in biology, chemistry, biochemistry, or a related discipline
  • Proven experience in Quality Assurance within the Life Science or Biotechnology sectors
  • Familiarity with cGMP and Quality Management Systems
  • Experience with ISO standards or equivalent frameworks

Desirable Qualifications:

  • Experience in supplier quality and customer support
  • Understanding of UK and EU regulatory requirements

Personal Attributes:

  • Collaborative team player with strong communication abilities
  • Detail-oriented and highly organized
  • Exceptional problem-solving capabilities
  • Adaptable with a positive mindset