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Specialist, Sterility Assurance

Req # 206686 Location Croydon, England, United Kingdom Additional locations Stockport, Cheshire; Dublin; Oxford, Oxfordshire Job Category Quality Date posted 07/28/2026
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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

Specialist, Sterility Assurance

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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. 

SUMMARY

The Sterility Assurance specialist provides technical expertise and support to the UK and Ireland Compounding Sites for all sterility assurance aspects. Acts as a valuable and effective source of information and advice on sterility assurance and positively contributes to the network Quality Management Team. Responsible for ensuring that the UK and Ireland Compounding Sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Responsible for ensuring effective Sterility Assurance and Environmental Monitoring programmes are deployed in UK and Ireland Compounding facilities, in compliance with current GMP and Baxter global strategy.
  • Provide technical support and guidance on Sterility Assurance, Environmental Monitoring, environmental control, Contamination Control Strategy and aseptic practices across UK and Ireland Compounding facilities.
  • Support risk management activities relating to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy and aseptic practices, including support of site RTRA processes as required.
  • Support the Global Compounding organization on standardisation of Sterility Assurance practices and identification and implementation of new technology for microbiological testing and environmental control
  • Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility Assurance, including risk reduction initiatives in line with company strategy
  • Provide coaching, mentoring and technical guidance to operational and quality teams in relation to Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices.
  • Provide technical oversight and interpretation of validation, qualification or study data related to Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, as required.
  • Support inspection readiness and participate in internal, corporate and regulatory audits as the technical representative for Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, as required.
  • Review and assess Environmental Monitoring reports and protocols to ensure compliance with regulatory standards and internationally acceptable standards.
  • Support and lead problem solving investigations for product and process deviations or customer complaints.
  • Participate in complaint investigation, non-conformance and quality incidents investigation, act as technical approver where required.
  • Provide technical input to change controls where Sterility Assurance, Environmental Monitoring, Contamination Control Strategy, environmental control or aseptic practices may be impacted
  • Provide technical support in the interpretation of microbial identification and Environmental Monitoring data, including trending of EM and microbiological data and setting of appropriate Alert limits
  • Support Environmental Monitoring Management Software approval, configuration and reporting.
  • Responsible for the tracking and reporting of Quality Metrics for internal and external use.
  • Support the development and review of of quality documentation including local SOPs and documents related to Sterility Assurance, Environmental Monitoring, Contamination Control Strategy and aseptic practices, acting as document owner or Technical Approver as required.
  • Provide microbiological expertise, training and operational guidance to operational and quality staff on Sterility Assurance, Environmental Monitoring, environmental control and aseptic practices, including periodic reassessment as required.
  • Identify new, or changes to existing, processes and systems to improve effectiveness and efficiency of the Sterility Assurance programme whilst maintaining compliance with Corporate and Regulatory requirements.
  • Adhere to Environmental Health & Safety (EHS) policies, procedures and requirements.
  • Support maintenance of a safe place to work through escalation of unsafe EHS practices
  • Maintain professional status and standards
  • Fully support the Quality Policy and business goals and objectives by building quality into all aspects of work.
  • Any other tasks from Sterility Assurance Manager. 

PERSONAL PROFILE AND ATTRIBUTES

  • Team player with a collaborative attitude. Ability to build strong relationships with internal and external customers.
  • Results oriented with excellent attention to detail
  • Self-driven with strong motivation to achieve and exceed results and able to work independently as required
  • Ability to prioritise work load and deliver against target, including under stressful conditions
  • Positive and proactive approach to problem solving
  • Strong interpersonal and communication skills with ability to work and communicate cross functionally within the Baxter Compounding cluster and wider Baxter network.
  • Computer literate in standard MS Office applications such as Word Excel, PowerPoint Word, SharePoint, Office 365 for generation of reports, presentations, analysis of data etc.
  • Knowledge of risk management tools and Lean Management principles

EDUCATION AND EXPERIENCE

  • Degree in Microbiology, although other Life Sciences degrees may be considered with relevant experience
  • Required 3 years’ experience in implementing environmental control programs and OOL investigation and correction
  • Preferred 5 years’ experience of microbiology experience in an aseptic facility
  • Strong operational experience preferably in an aseptic manufacturing background
  • Experience of aseptic technique
  • Excellent interpersonal skills
  • Passionate advocate of quality as a discipline and continuous improvement
  • Have experience in the use of quality improvement and problem solving skills (ie FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean manufacturing
  • Have experience of critical equipment and process Change Control
  • Able to work autonomously and take the initiative
  • Demonstrate
    • Critical thinking and decision making
    • Collaboration and teamwork
    • Dealing with ambiguity
    • Good management and communication skills
    • Customer and patient focus

What are some of the benefits of working at Baxter?

  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.

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Address

Explore this location Unit 1, Stafford Cross Business Park
Croydon
London
CR0 4TU
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.”

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