Quality Assurance Specialist – Biotech, ISO 9001 & eQMS

Bit Bio; Cambridge; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A biotechnology company is seeking a QA Specialist for a full-time, 12-month fixed-term contract based in Cambridge. The role involves supplier qualification, change control, and ensuring ISO 9001 compliance. Candidates should have a relevant Bachelor’s degree and experience in a regulated environment, particularly in pharmaceuticals or biotech. This position offers a hybrid work model in a dynamic and collaborative team environment.

Benefits

Creative and open work environment

Opportunities for personal development

Participation in cutting-edge projects

Qualifications

• Experience in a Quality Assurance focused role within a regulated environment.
• Proven supplier auditing experience.
• Hands-on eQMS proficiency and policy/SOP authorship.

Responsibilities

• Drive supplier qualification and audits.
• Guide teams to create high-quality change controls.
• Develop key quality policies/SOPs.

Skills

Supplier auditing

ISO 9001 knowledge

eQMS proficiency

Change-control governance

Quality Assurance experience

Education

Bachelor’s degree in a relevant scientific or engineering discipline

Tools

Veeva

NetSuite

Job description

A biotechnology company is seeking a QA Specialist for a full-time, 12-month fixed-term contract based in Cambridge. The role involves supplier qualification, change control, and ensuring ISO 9001 compliance. Candidates should have a relevant Bachelor’s degree and experience in a regulated environment, particularly in pharmaceuticals or biotech. This position offers a hybrid work model in a dynamic and collaborative team environment.