Quality Assurance Associate

Overview

In this role, you ensure quality across Baxter Elstree’s bone haemostat manufacturing operations. You will work within a close-knit team to balance GMP, ISO 13485, and FDA 21 CFR 820 requirements while supporting product release, testing, and investigation activities. The position involves hands-on QA in a cleanroom environment, coordinating testing with external labs, and contributing to the QMS. You help maintain compliance, drive continuous improvement, and support timely, safe release of products to surgeons.

Pay / Benefits

• 25 days annual leave plus bank holidays
• Up to 8% pension contribution
• Westfield healthcare
• Employee discount scheme
• Employee assistance programme
• Professional development opportunities

Responsibilities

• Sampling intermediate products and performing testing per SOP/Finished Product Specification
• Coordinate product testing with external contract laboratories
• Compile release data and bioburden information; support disposition of finished product
• Inspect goods and material dispositioning; coordinate investigations into non-conforming product
• Support calibration, maintenance, and revalidation activities for equipment and facilities
• Adhere to policies and participate in internal audits; support complaints and corrective actions
• Assist with quality investigations (NCR/CAPA/Complaint handling) and QMS documentation

Key requirements

• QA, cGMP and Quality Systems experience in an operational quality environment
• Knowledge of clean room control requirements
• Bachelor’s degree in scientific or technological subject
• 2+ years’ experience in GMP regulations related to medical devices/pharma/biologics
• 1–2 years supervisory experience preferred
• Internal auditing experience
• Familiarity with NCR/CAPA, complaint and document control processes within a regulated QMS
• Ability to work in fast-paced, changing environments and support new product introductions
• Excellent investigative, analytical and problem solving skills
• Strong verbal and written communication skills

• strong communication
• analytical thinking
• problem solving
• ISO 13485
• FDA 21 CFR 820
• GMP

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