Quality Assurance Specialist

Job title: Quality Assurance Specialist

Reports to: Quality Manager

Location: Eastleigh, Hampshire (SO53 4DG)

Contract Type: Full-time, Permanent

Salary & Benefits: Competitive Salary + Benefits Package

About Novacyt:

At Novacyt, we pride ourselves on concentrating our expertise on specific market needs. Offering a comprehensive and developing portfolio of quality products, backed by proven supply and delivery services, to ensure the highest possible standards of customer service around the world.

Our passion is for customer-centric solutions that advance the science behind diagnostics. This fuels our drive to deliver products that save lives and help in the fight against infectious disease. We offer an increasing portfolio of in-vitro diagnostic tests, utilising molecular and protein detection technologies – supporting healthcare and disease prevention across the globe in the clinical and life science sectors. Deep strengths in product development, commercialisation, contract design, and manufacturing ensure quality products and robust supply.

Description of role:

We have a fantastic opportunity for a QA Specialist to join our quality assurance team on a full-time and permanent basis.

Overall responsibility:

The QA Specialist 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. You will be supporting the Primer Design Ltd. Quality team responsible for the continuing improvement and maintenance of compliance with all relevant Quality Management System standards identified by the company.

Key areas of responsibility:

• 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. Provide guidance to achieve timely release of compliant products, 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.
• The completion of relevant QA activities deemed appropriate to the success of the Quality department.

Qualifications, Skills and Abilities:

Required

• 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.

Closing Date:

Sunday 13th October, 2024

Novacyt Group is committed to encouraging equality, diversity and inclusion among our workforce. The aim is for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best.