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Quality Assurance Officer
2 months ago
Bio-Techne, a world-leading developer and manufacturer of high-quality life science reagents, is seeking a Quality Assurance Officer to join their growing team in their QA department in Bristol.
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 Release: Review, approval, and release of Batch Production Records and Quality Control testing data.
- Non-Conformance Management: Coordinate and approve/manage to completion any non-conformances, deviations, and out-of-specifications.
- CAPA Management: 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 and Development: 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 Management: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials.
- Environmental Monitoring: 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.
Education and Experience
- 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 Qualifications
- 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-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.
