Senior Quality Assurance Officer

2 months ago

Bristol, Bristol, United Kingdom Bio-Techne Full time
Senior QA Officer Job Description

At Bio-Techne, we are committed to product quality, customer satisfaction, and continued improvement. We are seeking a highly skilled Senior QA Officer to join our team and contribute to our mission.

Key Responsibilities:
  • Lead the review, approval, and release of Batch Production Records and Quality Control testing data.
  • Coordinate and approve/manage to completion any non-conformances, deviations, and out of specifications.
  • Coordinate and approve/manage to completion any CAPA raised, ensuring adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
  • Document Management: Write, review, and approve internal procedures, release and issue procedures, and archive previous revisions.
  • Change Control: Lead Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
  • Internal Audits: Participate in the completion of the internal audit schedule, conduct internal audits, report any findings, and track completion of corrective actions.
  • External/Customer Audits: Lead preparation activities and be responsible for backroom activities during external/customer audits.
  • Technical Support: Provide 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.
  • 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.
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 maintaining Quality Management Systems to ISO 9001, ISO 13485, 21CFR part 820, or EudraLex Volume 4, Part II.
Desirable:
  • 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-oriented, and highly organized.
  • 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.

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