QA Associate - GMP/Regulatory, Product Release

Baxter; St Albans; On-site; GBP 32,000 - 52,000; Full time

Benefits offered by this job

Support for Parents

Continuing Education

Professional Development

Employee Health

Paid Time Off

Volunteer Days

Pension

Healthcare

Employee Discount

Employee Assistance

Competitive Salary

Diversity & Inclusion

Job summary

Baxter Elstree is recruiting a QA Associate to support GMP compliance, product release and continuous improvement within a fast-paced manufacturing environment.

The role includes sampling, testing per SOPs, investigation handling (NCR/CAPA/complaint), internal audits, and coordination with external contract laboratories, with 7:30–16:00, Monday–Friday schedule on-site at Elstree. Strong attention to detail and communication are essential to protect patient safety.

Qualifications

• Bachelor's degree in a scientific or technical field is required.
• Experience with GMP regulations for medical devices/pharma/biologics is essential.
• Internal auditing experience and NCR/CAPA familiarity are preferred.

Responsibilities

• Sampling of intermediate products within the manufacturing process.
• Testing and inspection of product as required by SOP and Finished Product Specification.
• Co-ordination of product testing with external contract laboratories.
• Maintain compliance with ISO 13485 and FDA (21 CFR) part 820 and MDSAP.
• Compilation of release data and support for disposition/release of finished product.
• Support calibration, maintenance and revalidation activities for equipment and facilities.
• Adhere to QMS and assist in internal audits and quality investigations.

Skills

GMP Regulations

Quality Assurance

Internal Auditing

NCR/CAPA

Complaint Handling

Document Control

Data Analysis

Communication

Clean Room Knowledge

cGMP Knowledge

Quality Systems

Education

Bachelor's degree in scientific or technological subject

Job description

Baxter Elstree is recruiting a QA Associate to support GMP compliance, product release and continuous improvement within a fast-paced manufacturing environment.

The role includes sampling, testing per SOPs, investigation handling (NCR/CAPA/complaint), internal audits, and coordination with external contract laboratories, with 7:30–16:00, Monday–Friday schedule on-site at Elstree. Strong attention to detail and communication are essential to protect patient safety.