Skip to main content

QA Associate

Req # JR - 158575 Location St Albans, England, United Kingdom Job Category Quality Date posted 01/23/2025
Apply Now

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

QA Associate

Apply Now

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 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, we offer an attractive salary along with 25-days 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 role.

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 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.

Experience / Qualifications

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

  • Bachelor’s degree in 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.

#IND-UKOPS

#LI-BAXGEN

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Apply Now

Address

Explore this location ApaTech Limited 360 Centennial Avenue Elstree
Hertfordshire
Hertfordshire
WD6 3TJ
United Kingdom
Explore This Location

Hear from Our Employees

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.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“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.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

Related Content

You have not recently viewed any jobs.

Please browse jobs and click the 'Save Job' button for the jobs you are interested in.

Then you will be able to see your saved jobs here.

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

Join Now