QA Associate
On-site · Cambridge, England, United Kingdom
Job Summary
QA Associate sought to help establish and maintain Avantor’s Quality Management System (QMS) in a brand-new laboratory environment. Responsibilities include reviewing, evaluating, and approving document changes; managing documentation in the eQMS; coordinating training; collaborating with Operations and Scientific teams; explaining QA processes to scientists; processing complaints and nonconformances; supporting CAPA activities and change control; monitoring KPIs related to lab quality; participating in supplier evaluations; contributing to internal audits and continuous improvement initiatives. Requires a science-related Bachelor’s degree (or equivalent quality-role experience) and strong communication, organizational, and analytical skills; experience with regulated environments and documentation is essential. Nice-to-have experience in medical device or IVD industries, lab start-up/scale-up, and familiarity with FDA QSR and ISO standards. EEO statements and company overview included.
Required Qualifications
- Bachelor’s degree in a science-related field, or equivalent experience in a quality role within a clinical lab environment
Desired Qualifications
- Bachelor’s degree in a science-related field
- equivalent experience in a quality role within a clinical lab environment
- experience supporting documentation processes within a regulated environment
- experience with electronic Quality Management System (eQMS)
- excellent communication and organizational skills
- ability to collaborate with cross-functional teams
- knowledge of FDA QSR and ISO standards (nice to have)
- experience with CAPA processes (nice to have)
- experience in lab start-up or scale-up environments (nice to have)
- proactive problem-solving mindset
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