Quality Assurance Officer

Quality Assurance Officer

Biotechnology Life Sciences

Location York, Yorkshire.

Salary Up to £23,500

Contract Permanent

Reference KMQA02

Date Posted

Consultant


Are you an organised individual with a competency for ensuring quality standards are met within a business? An exciting opportunity is now available within a rapidly growing life sciences company based near to the historic city of York! The company are looking to hire an individual who shares their passion for the betterment of people’s lives.

As a Quality Assurance Officer, you will work with the group quality management to ensure the compliance of the business’ quality management system to established ISOs and other regulatory guidelines. You will also cooperate with the transaction of on-site audits, customer related issues, and the maintenance of calibration, servicing, and quality records. You will be organised and able to manage large quantities of data as well as competent within the use of operating systems and software to identify and manage risks, areas of improvement and review and approve product release.

Main Responsibilities:

  • Working with the Group Quality Manager, complying to the business’ Quality Management System in line with ISO 9001:2015, ISO13485:2016 and 21CFR 820. Further assist Group Quality Manager through maintaining calibration and servicing calendar to arrange servicing and record keeping.
  • Cooperate with on-site audits, including those conducted by external providers and customers.
  • Investigate customer and non-conformance issues.
  • Reviewing, approving and issue of Certificates of Analysis and Product Release.
  • Collect and analyse statistical quality data, to identify areas for improvement in the quality system. Then develop and monitor corrective and preventive actions.
  • Communicate the outcomes of quality activities such as post market surveillance, CAPA analysis via reports.
  • Maintain the Quality Records within the company archive.
  • Participate in New Product Development, Product Change and Product transfer activities.

You will have:

  • A good knowledge of ISO 9001:2015, ISO13485:2016 and 21CFR 820 and the ability to work in compliance with those guidelines.
  • Exceptional organisational skills, prioritising tasks to effectively meet deadlines.
  • The ability to effectively manage your time to manage deadlines and work effectively with the other operational teams to ensure efficient service.

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]

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Quality Assurance Officer

Biotechnology Life Sciences

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