QA Associate - (Night Shift)

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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

QA Associate - (Night Shift)

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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.

Summary:

The Quality Assurance Associate will be responsible to support in the continuous compliance of Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies and assisting quality operation through the release of compounded product

They will ensure timely communication of significant GMP and product quality issues to QA Management, proactively identify and support implementation of continuous improvement opportunities in QA and Operations and investigate and report on Quality issues.

This role will work Sunday - Thursday between the hours of 6pm and 2pm.

Essential Duties and Responsibilities:

Assist in the release of manufactured products according to defined procedures

Perform ‘in-process’ checks, report and record any errors (e.g. CPI/NCR) according to defined procedures including:
- Green Light to Release:
  - Facility status checks
  - Equipment and validated state checks
  - Physical product checks
  - Manufacturing and documentation checks
  - Check of any outstanding Quality issues with the batch or facility.
- Supervisor checks throughout the compounding process (picking to release)

Escalate and resolve any observed product quality issues in a timely manner, ensuring GMP is adhered to at all times.
Ensure product complaints and service complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented

Ensure that a schedule of environmental monitoring is in place that complies withGMP and that any out of limits or alerts are investigated and actions taken to correct and EM trend analysis

Ensure facility and process compliance through Real Time Risk Assessments and GEMBA walks, identifying actions and facilitating implementation.
Proactively identify and support implementation of continuous improvement opportunities in QA and Operations.
Comply with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements.
Review and approve planned and unplanned controlled system work orders (CSW) & Maximo.
Raise and Investigate non-conformance reports (NCRs), define, execute and track appropriate CA/PA actions
Support reviews of production processes (to meet regulatory and customer requirements) from a quality prespective
Support the qualification, maintenance and calibration activities from quality prespective as needed
Identify and escalated supplier issues supporting their investigation as per SCARs (Supplier Corrective Action Requests) or B2B (Baxter to Baxter complaints) process.

Education and Qualifications

Eligibility required: Resident and eligible to work in the UK or Ireland on a full-time basis.

Education:

English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5
Degree or BTEC (or equivalent) in Pharmaceutical or Science related subject

Experience and Attributes:

Required;

2 Years experience in a GMP Environment
Field of expertise preferred: Quality Assurance Production, Validation, Microbiology
Aseptic Manufacture of medicinal products is preferred but not required

Preferred:

Strong working knowledge of Microsoft Office programmes including Excel
Experience of TrackWise8 and TrackWise9

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
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.”

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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QA Associate - (Night Shift)

Overview

Success Profile

QA Associate - (Night Shift)

Address

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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

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Join Our Talent Community