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Senior Quality Assurance Officer
2 months ago
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.
- 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.
- 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.