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Quality Assurance Specialist

2 months ago

Chandler's Ford, United Kingdom Novacyt Group Full time
About Novacyt Group

Novacyt Group is a leading provider of in-vitro diagnostic tests and solutions for the clinical and life science sectors. Our passion is for customer-centric solutions that advance the science behind diagnostics, and we offer an increasing portfolio of in-vitro diagnostic tests, utilising molecular and protein detection technologies.

Job Title: Quality Assurance Specialist

We are seeking a highly motivated and experienced Quality Assurance Specialist to join our quality assurance team on a full-time and permanent basis. The successful candidate will be responsible for ensuring our product and services meet the established standards of quality, including the product is fit for purpose, safe and effective in use.

Key Responsibilities:
  • Responsible for document management system(s).
  • Assure ongoing compliance with quality and industry regulatory requirements.
  • Assist the business to support the Quality management system in place.
  • Identify training needs and organise training interventions to meet quality standards.
  • Ensure the timely release of compliant, safe, functioning product through collaboration with all departments.
  • Document internal audits and other quality assurance activities.
  • Provide guidance to achieve timely release of compliant product, leading to increased customer satisfaction and safety.
  • Conduct and record internal audits and other quality assurance activities.
  • Investigate non-conformance issues and identifying root cause and implementation of corrective and preventive actions.
  • Analyse data/KPIs to monitor, identify trends and areas for improvement in the quality system.
  • Present quality data at regular multi-department meetings to meet quality objectives.
  • Design inputs, outputs and verification.
  • Supplier Management and perform supplier audits as required.
  • Support on-site audits conducted by external providers.
Requirements:
  • At least 1-2 years' experience of working in QA.
  • Experience of working with quality management system standards e.g. ISO 9001/ISO 13485.
  • Logical, pragmatic approach to problem solving.
  • Knowledge of Good Documentation and Manufacturing Practices.
  • Experience of documentation control, product release, OOS (QC), Change Control, Non-conformances and CAPA.
  • Strong computer skills including Microsoft Office, QA applications and databases.
  • Flexible, able to work in a fast-paced environment to meet set deadlines.
Preferred:
  • Experience of using an e-QMS.
  • Experience managing suppliers and sub-contractors from a quality perspective.
  • Conducting internal audits and internal audit Certification.
  • Experience of conducting training.