Description
By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of 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:
Bio-Techne is a world-leading developer and manufacturer of high quality life science reagents and is seeking a QA Officer to join their growing team in their QA department in Bristol.
This successful candidate, reporting to the Quality Assurance Leader, will join a vibrant and dynamic Quality Assurance team covering Quality Assurance tasks relating to development and manufacture of GMP and RUO products. This is an exciting opportunity for a QA Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems.
Key Responsibilities:
• Batch Record review and product: 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: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
• Training: Organise and participate in internal quality related training sessions.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings and tracking completion of corrective actions.
• Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials.
• Environmental Monitoring of the ISO 7 Cleanroom during weighing operations.
• Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
• 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 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.
