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By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.
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.
Position Summary:
The Senior QA Officer will work alongside the QA Team Leader to coordinate and lead the daily operations of the business maintaining compliance to the QA requirements across all product types and business areas. Responsible for leading activities that support CGT manufacture and weighing schedule. Responsible for managing the Campaign reviews. The Senior QA Officer will mentor and coach other QA Officers in quality requirements and business practices.
Reporting to the QA Team Leader the Senior QA Officer will be a highly collaborative and proficient individual with excellent communication skills.
Key Responsibilities:
• Leading activities that support the CGT manufacturing and weighing schedules.
• Lead the review, approval and release of Batch Production Records and Quality Control testing data.
• Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
• CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
• Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
• Change Control: Lead Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
• Experienced internal auditor for ISO 9001, ISO13485 or cGMP.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actions.
• External/Customer Audits: Lead preparation activities and responsible for backroom activities during external/customer audits.
• Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
• Work closely with Quality, Manufacturing, Supply Chain and Facilities teams to identify and support the Quality System compliance and customer needs. Uses initiative and adapts to shifting priorities.
• Training: Lead internal quality related training sessions for the business.
• Experienced in Product disposition and 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.
• Coach and mentor team members on quality assurance and business requirements including best practices.
• Foster and support a culture of high performance, creativity, teamwork and Bio-Techne’s EPIC values.
• Any other task as required by the business.
Qualifications
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 maintaining Quality Management Systems to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.
• Experienced in supplier quality processes.
• Experienced in investigation of customer complaints and customer technical support.
• 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.
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