Snr Quality Systems Associate

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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

Snr Quality Systems Associate

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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.

Your Role at Baxter

This is where your creativity addresses challenges

The Senior QS Associate will be responsible for leading and supporting initiatives to ensure the continuous compliance of the UK Compounding business to cGMP and “Specials” manufacturing requirements, local procedural requirements, and Baxter Corporate policies. This role will focus on providing quality systems support across the UK compounding network.

Reports into the UK Compounding Quality System Manager.

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior QS Associate, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What you'll be doing

Ensure compliance with applicable GMP, GDP, MHRA, and other relevant regulatory standards.
Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with corporate and regulatory requirements.

Stability and Temperature Excursion Management

Review Baxter stability studies, product SmPCs, and relevant scientific literature to define compounded product stability data.
Assess and document temperature excursion incidents within the Quality System.
Own and lead Temperature Excursion Evaluation Tasks, ensuring timely and thorough investigation.
Review and approve temperature excursion documentation and provide product disposition assessments.
Support the management of stability records in the Pharmacy electronic systems Merlin and Mercury
Raise significant excursions through the nonconformance process
Ensure regulatory reporting of issues to local Regulatory Authorities as required

Field Actions and Recalls

Lead and coordinate field actions and product recalls in accordance with Baxter procedure.
Ensure effective communication and documentation throughout the recall process.
Liaise with internal and external partners such as MoH, Baxter Compounding Units, Baxter Commercial and Medical Affairs teams, Baxter Homecare, etc.
Collaborate with cross-functional teams to assess impact and implement corrective actions.
Lead and raise significant quality issues within the Global Compounding Organization for the purposes of Senior Management and other Compounding sites awareness

Audit Management:

Lead and support Internal, Corporate and external/Regulatory, audits
Support site’s audit readiness activities.
Lead and support in the annual internal audit program as required.
Track and trend relevant unit audit findings.

Other duties you will also be involved in as part of the role:

Introduction of New Drugs and Components

Change Control Process

Corrective & Preventive Action Processes

Documentation

Quality Management Review (QMR)

Communication and Training

What you'll bring

English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5
At least 2 years’ experience in the pharmaceutical or medical device industry.
Proven knowledge of Quality System processes.
Bachelor’s degree or higher in Pharmaceutical, Biotechnology, Chemistry or Microbiology
Minimum of 2 years' experience in quality team facilitation, project management, process improvement, or quality data analysis role.
Experience of coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance, and Complaints processes.
Experience of problem-solving using Root Cause Analysis techniques such as GEMBA, 5 Whys, Cause and Effect.
Working knowledge and hands-on experience of software tools to lead Quality Systems processes such as TrackWise.
Report and documentation writing skills.
Risk management tools and methods.
Excellent verbal and written communication skills.

What are some of the benefits of working at Baxter?

Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Commitment to growing and developing an inclusive and diverse workforce

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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 Baxter Thames Valley Unit Taurus Building Unit 2, Peterley Road Horsepath Industrial Estate, Cowley
Oxford
Oxfordshire
OX42TZ
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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.”

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.

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Snr Quality Systems Associate

Overview

Success Profile

Snr Quality Systems Associate

Your Team at Baxter

What you'll be doing

Stability and Temperature Excursion Management

Field Actions and Recalls

Audit Management:

What you'll bring

#li-sh1

Address

Share

Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

Related Content

Join Our Talent Community