QA Associate

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

• 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 the requirements of MDSAP.

Product Release

• Compilation of release data for finished products.
• Co-ordination of product bioburden data.
• Collation and completion of documentation to support release.
• Inspection of sterilized finished product received back from subcontractors.
• Support to releasers for disposition/release of finished product.

Goods Inwards Quality Control

• Inspection of goods and material dispositioning.
• Co-ordination of investigations into non-conforming product.

Calibration/Maintenance Control

• Support of calibration, maintenance and revalidation activities for equipment and facilities.
• Monitoring of schedule and tracking execution of activities.

Quality Assurance/Control

• Adherence to Baxter Elstree's relevant policies and procedures at all times, and notification of any deviations/exceptions from process.
• Support for all aspects of the QMS through participation in internal audit as trained and approved auditors and support for incidences such as complaints, and any subsequent field corrective actions/recalls.
• Support for and co-ordination of Quality Investigations i.e. NCR/CAPA/Complaint handling, and logging/issuing of QMS numbers., "I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety." Detail Oriented

• Continuous Learner
• Courageous
• Collaborative
• Critical Thinker
• Influential, QA, cGMP and Quality Systems in an Operational Quality environment. Knowledge of clean room control requirements.
• Bachelor's degree in scientific or technological subject
• A minimum of 2 plus years' experience required in the areas of GMP regulations that pertain to the medical devices / pharma / biologics - Quality, Manufacturing, Engineering or related field which where possible 1-2 years of supervisory experience is preferable
• Internal Auditing experience. Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System.
• Working in a fast paced, rapidly changing environment, supporting new product introduction.
• Excellent investigational, analytical and problem solving skills. Ability to review and monitor data, and identify trends.
• Highly proficient communicator, both verbal and written.
• This is where your work makes a difference.
• At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride.
• Our Elstree site is currently recruiting for a QA Associate. Baxter is a global pharmaceutical company who manufacture many lifesaving products but here in Elstree we specifically manufacture bone haemostats which is synthetic bone graft material for Surgeons to use in operating theatres. The site has 36 employees so although a large company, we remain a close-knit team, with some of our employees having been here over 20 years.
• This role is Monday-Friday 7:30 - 4pm, Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

• Support for Parents
• Continuing Education/ Professional Development
• Employee Health & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer, 25 days annual leave plus bank holidays (Increasing with service)
• Up to 8% pension contribution
• Westfield healthcare
• Employee discount scheme
• Employee assistance programme
• Competitive salary + local bonus
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce