Education and Experience
Essential:
• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• Experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience of working within a cGMP environment.
• Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.
Desirable:
• Experienced in conducting final QA product release
• Experienced in the critical review of CAPA / non-conformances / deviations / OOS
• Experienced in documentation management systems and change control processes from a Quality Assurance perspective
• Experienced internal auditor for ISO 9001, ISO 13485 or cGMP
• Experienced in supplier quality processes
• Experienced in investigation of customer complaints and customer technical support
• Experience of conducting environmental monitoring of cleanrooms
• Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products
Personal Qualities and attributes:
• Excellent team working skills
• Ability to critically review documentation
• Methodical, process orientated and highly organised
• Excellent attention to detail
• Excellent time management skills
• Excellent verbal and written communication skills in English
• Problem solving ability
• Flexible with a can-do attitude
Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.