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
Quality Assurance Associate employer: Baxter International
At Baxter, we are committed to redefining healthcare delivery and making a meaningful impact on lives. Our collaborative culture fosters personal growth and professional development, ensuring that every employee feels valued and empowered to contribute to our mission of saving and sustaining lives. With a focus on innovation and a brand-new compounding department in Thetford, you will have the unique opportunity to shape the future of healthcare while enjoying a competitive compensation package and a strong emphasis on work-life balance.
