QA Associate – GMP/Pharma, Cleanroom QC

Baxter; Borehamwood; On-site; GBP 28,000 - 40,000; Full time

Benefits offered by this job

25 days annual leave plus bank holiday

Pension contribution (up to 8%)

Westfield healthcare

Employee discount scheme

Employee assistance programme

Competitive salary + local bonus

Professional development opportunities

Work-life balance emphasis

Diversity & inclusion

Job summary

Baxter Elstree site is seeking a QA Associate to support GMP quality activities across product testing, release, and investigations. You will work in a cleanroom environment, ensuring compliance with ISO 13485 and FDA requirements, and coordinate with contract labs for testing and release documentation.

The role requires a scientific degree, 2+ years in regulated QA, and strong analytical and communication skills in a fast-paced setting. Monday–Friday operations with a focus on QA/QMS adherence.

Qualifications

• Bachelor's degree in scientific or technological subject.
• Minimum 2+ years' experience in GMP regulations related to medical devices/pharma/biologics.
• Internal auditing experience; familiarity with NCR/CAPA and complaint handling in a regulated QMS.
• Excellent investigational, analytical and problem solving skills; strong written and verbal communication.

Responsibilities

• Testing and inspection of product as per SOP and Finished Product Specification.
• Coordinate product testing with external contract laboratories.
• Maintain compliance with ISO 13485 and FDA 21 CFR 820 and MDSAP.
• Support product release by compiling release data and coordinating bioburden data.
• Inspect goods and materials for dispositioning at Goods Inwards QC.
• Investigate non-conforming product and drive CAPA actions.
• Assist calibration, maintenance and revalidation of equipment and facilities.
• Support internal audits and incident investigations under the QMS.

Skills

GMP compliance

Auditing

Analytical skills

Communication

Quality systems

Education

Bachelor's degree in science/tech

Job description

Baxter Elstree site is seeking a QA Associate to support GMP quality activities across product testing, release, and investigations. You will work in a cleanroom environment, ensuring compliance with ISO 13485 and FDA requirements, and coordinate with contract labs for testing and release documentation.

The role requires a scientific degree, 2+ years in regulated QA, and strong analytical and communication skills in a fast-paced setting. Monday–Friday operations with a focus on QA/QMS adherence.