Quality Assurance Associate - Onsite Audits & Document Control

Azenta LTD; Dorking; On-site; GBP 32,000 - 52,000; Full time

Job summary

Azenta UK, Ltd. seeks a Quality Assurance Associate to maintain and improve the Quality Management System across manufacturing sites in the UK. You will oversee internal audits, host customer audits, and support certification body audits to ensure ISO 9001 and ISO 13485 compliance.

Gatekeeping document control at the Wotton site is a key responsibility. The role requires collaboration with cross-functional teams, ensuring on-time training, and continuous quality improvements.

Qualifications

• Bachelor's or Associate Degree in Life Science, Chemistry, Engineering or related field.
• Internal Auditor experience preferred, Lead Auditor certification desirable.
• Strong understanding of Change Control, Document Control and 8D methodology.

Responsibilities

• Gatekeep the document control process and ensure training on new/updated processes is completed on time.
• Conduct regular internal audits of manufacturing processes and documentation for compliance.
• Host customer audits and coordinate with cross-functional teams to address findings.
• Prepare for and participate in Certification Body audits and ISO 9001/13485 requirements.
• Monitor quality indicators and report trends to senior leadership.

Skills

Internal Auditor

Lead Auditor

Document Control

Change Control

8D methodology

ISO 9001/13485

Audit coordination

Education

Bachelor's or Associate Degree in Life Science or related field

Tools

Windows

Microsoft Office (Teams, Excel, Visio)

Planner / MS To-Do

Job description

Azenta UK, Ltd. seeks a Quality Assurance Associate to maintain and improve the Quality Management System across manufacturing sites in the UK. You will oversee internal audits, host customer audits, and support certification body audits to ensure ISO 9001 and ISO 13485 compliance.

Gatekeeping document control at the Wotton site is a key responsibility. The role requires collaboration with cross-functional teams, ensuring on-time training, and continuous quality improvements.