Quality Assurance Specialist
3 weeks ago
About the Role
Bio-Techne is seeking a highly skilled Quality Assurance Specialist to join their Quality Assurance team in Bristol. As a Quality Assurance Specialist, you will play a crucial role in maintaining the current Quality Systems and contributing to their continual improvement.
Key Responsibilities
- Review, approval, and release of Batch Production Records and Quality Control testing data
- Coordinate and approve non-conformances, deviations, and out of specifications
- Coordinate and approve CAPA raised, ensuring adequate root cause analysis and implementation of corrections or corrective/preventative actions
- Document management, including writing, reviewing, and approving internal procedures, releasing, and archiving previous revisions
- Change control, reviewing and approving changes to procedures and processes
- Organize and participate in internal quality-related training sessions
- Participate in internal audit schedule, conducting audits, reporting findings, and tracking completion of corrective actions
- Assist in QA approval of incoming materials and approval of QC testing for incoming materials
- Environmental monitoring of the ISO 7 Cleanroom during weighing operations
- Provide technical support as required for customer enquiries and supporting associated customer complaint investigations
Qualifications and Attributes
- BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field
- Experience working in a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science, or Biotechnology company
- Experience working in a cGMP environment
- Experience working to ISO 9001, ISO 13485, 21CFR part 820, or EudraLex Volume 4, Part II
At Bio-Techne, we are 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 a vital part of our culture.
About Bio-Techne
Bio-Techne is a world-leading developer and manufacturer of high-quality life science reagents. We provide tools for researchers in Life Sciences and Clinical Diagnostics, and we are dedicated to supporting the advancement of scientific knowledge and discovery.
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