Azenta UK, Ltd.At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity.
Quality Assurance Associate
The Quality Assurance Associate works closely with quality teams to maintain and improve the Quality Management System across multiple manufacturing sites. The role supports Azenta’s QMS in accordance with FDA Quality System Regulation and oversees internal audits, customer audits, and certification body audits to ensure compliance with ISO 9001 and ISO 13485. This position also gates the document control function at the Wotton site and collaborates with cross‑functional teams while working independently.
What You’ll Be Doing
- Document Control
Act as gate keeper for the document control process, ensure training on new and updated processes is completed on time, and create and progress document‑related change controls as needed.
- Internal Audits
Conduct regular internal audits at both manufacturing locations, evaluate processes, procedures, and documentation to ensure compliance with quality standards, and identify areas for improvement with corrective action recommendations.
- Customer Audits
Host customer audits as required, coordinate with cross‑functional teams to provide necessary information, address findings, and maintain positive relationships with customers during the audit process.
- Certification Body Audits
Prepare for and participate in certification body audits, ensure compliance with ISO 9001 and ISO 13485 requirements, and collaborate with relevant departments to address non‑conformities.
- Quality Monitoring and Reporting
Assist QA with monitoring quality indicators and trends, report findings to senior leadership, and identify training needs and deficiencies related to quality.
- Communication and Collaboration
Communicate effectively with senior leadership, colleagues, and global teams; collaborate with other departments (Engineering, Manufacturing, etc.) to maintain quality standards.
What You’ll Bring
- Excellent oral and written communication skills.
- Experience with document control and change control.
- Experience in batch release / product release processes.
- Familiarity with Microsoft Office applications, business mathematics, and database tools.
- Understanding of inspection and audit methods.
Qualifications
- Bachelor’s or Associate Degree in Education, Life Science, Science, Chemistry, Business, Engineering, or a related field.
- Internal Auditor experience preferred; expected to obtain and maintain a Lead Auditor Certification.
- Two years of experience in quality assurance or related field with a working knowledge of Change Control, Document Control, and 8D corrective action methodology.
- Ability to understand complex documents related to life sciences and medical device design and manufacture such as Quality Manual (QM), Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Post‑Market Surveillance (PMS), Instructions For Use (IFUs), Periodic Safety Update Report (PSUR), etc.
- Organizational and project management skills; ability to manage multiple projects and meet deadlines, utilizing modern task tracking techniques.
- Proficiency with the Windows platform, Microsoft Office programs including Teams, Excel, Visio, and related apps such as Planner/MS Do/Tasks or equivalents.
- Strong teamwork skills and ability to facilitate presentations and training programs to individuals and/or large groups at all organizational levels.
Azenta is an Equal Opportunity Employer. This company considers candidates regardless of race, color, age, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status.
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