Senior Quality Assurance Officer
Biotechnology Life Sciences
Salary c. £25-£30k
Salary: c. £25-£30k.
An exciting opportunity to join the Quality Team as a Senior Quality Assurance Officer within a growing life sciences company based near to the historic city of York has arisen. The company are looking to hire an individual who exhibits their passion for the betterment of people’s lives and has a keen interest in assuring quality standards are met within business.
As a Senior Quality Assurance Officer, you will principally be responsible for the super use of Quality Management Systems as well as training and document management. You will effectively communicate with other team members to promote GMP, GDP and GLP and ensure work across all areas is completed in compliance with regulatory guidelines.
- Ensuring the company works in compliance with ISO 9001, ISO13485 and 21 CFR820. As well as the daily management of the established QMS System.
- Effectively communicate with other team members and function to solve problems. Promote GMP, GDP and GLP to new staff and section leaders, as well as providing QA support for tech transfer team.
- Support in the preparation for certification audits, customer audits and supplier audits. If necessary, act as lead auditor.
- Undertake the review and co-ordination of investigations, CAPA, batch records and effectiveness checks. Lead with post market surveillance reports writing (QA).
- Maintenance of the calibration and servicing calendar, assisting with the arrangement of calibration, servicing and record keeping.
- Support the Quality Director, ensuring processes needed for the QMS are established and maintained, whilst being aware of the need for continual improvement within these areas.
- Prepare quality documentation and reports by collecting and analyzing information and trends including failed processes, recalls, corrective actions, and re-validations.
- Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits, investigating customer issues, and implementing training sessions/workshops.
You will have:
- Good knowledge of ISO 9001, ISO13485 and 21 CFR820. Ensuring work is completed in accordance to established guidelines.
- Effective time management skills to meet deadlines.
- Keen attention to detail and problem-solving abilities to overcome technical issues.
- Knowledge of quality systems and a proficiency in operating systems and other technologies.
- Ability to convey information effectively via written and/or verbal methods.
The company offer a variety of benefits including 25 + 8 days holiday, company pension (6% company contribution after probationary period), cycle to work scheme, active wellbeing and events calendar, SAYE scheme 1 year after joining, subsided gym membership and an employee recognition scheme with the opportunity to be awarded £250 if nominated!
If this opportunity interests you, apply with your CV to [email protected]