QA Associate

Baxter Healthcare; St Albans; On-site; GBP 30,000 - 50,000; Full time

Job summary

Join a dedicated team at a leading global pharmaceutical company where your contributions directly impact patient care. As a QA Associate, you will play a vital role in ensuring the quality and compliance of lifesaving products. This hands-on position involves sampling, testing, and coordinating with external laboratories, all within a cleanroom environment. You will also support quality investigations and participate in internal audits, helping to uphold the highest standards of quality assurance. If you are passionate about making a difference in healthcare and thrive in a fast-paced environment, this opportunity is perfect for you.

Benefits

25 days of annual leave + bank holidays

Shutdown between Christmas and New Year

Attractive salary

Qualifications

• 1+ years in QA, cGMP, and Quality Systems in a regulated environment.
• Bachelor's degree in a scientific or technological field required.

Responsibilities

• Sampling and testing of products in the manufacturing process.
• Maintain compliance with ISO 13485 and FDA regulations.
• Support calibration and maintenance activities for equipment.

Skills

QA

cGMP

Quality Systems

Analytical Skills

Problem-Solving Skills

Communication Skills

Education

Bachelor’s degree in a scientific or technological subject

Tools

ISO 13485

FDA regulations (21 CFR part 820)

Job description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Our Elstree site is currently recruiting for a QA Associate. Baxter is a global pharmaceutical company that manufactures 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. We offer an attractive salary along with 25 days of annual leave + bank holidays. We also have a shutdown between Christmas and New Year.

As part of the role, the manufacturing area is a grade IS07 & IS08 cleanroom, which requires full PPE (gown, goggles, hair net, and full cleanroom suit). Please only apply for this role if you believe you would feel comfortable in this PPE.

This role is very hands-on, and you will spend time in the cleanroom and labs as part of your responsibilities.

Essential Duties and 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 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 audits 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.

Experience / Qualifications

• QA, cGMP, and Quality Systems in an Operational Quality environment. Knowledge of cleanroom control requirements is beneficial.

• Bachelor’s degree in a scientific or technological subject or equivalent.

• A minimum of 1 year's experience required in the areas of GMP regulations that pertain to the medical devices/pharma/biologics - Quality, Manufacturing, Engineering, or related field.

• Internal Auditing experience would be an advantage. 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.