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Quality Systems Coordinator
2 months ago
About Bio-Techne
Bio-Techne is a leading provider of tools and services for researchers in the Life Sciences and Clinical Diagnostics industries. Our commitment to product quality, customer satisfaction, and environmental responsibility is at the heart of our company culture.
Job Summary
We are seeking a highly skilled and experienced Senior Quality Assurance Officer to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products and processes.
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.
- Manage documentation, including writing, reviewing, and approving internal procedures, releasing and issuing procedures, and archiving previous revisions.
- Lead the review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
- Participate in internal audits, conducting audits, reporting findings, and tracking completion of corrective actions.
- Lead preparation activities and be responsible for backroom activities during external/customer audits.
- 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 Quality System compliance and customer needs.
- Lead internal quality-related training sessions for the business.
- Experience in product disposition and release, critical review of CAPA/non-conformances/deviations/OOS, 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
- Experience in supplier quality processes.
- Experience 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.
