Quality Assurance Specialist

3 weeks ago


Bristol, Bristol, United Kingdom Bio-Techne Full time

Job Description:

Bio-Techne is a world-leading developer and manufacturer of high-quality life science reagents. We are seeking a highly skilled QA Officer to join our growing team in Bristol, UK.

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: Organize 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.

Requirements:

  • 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.


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