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For Companies At a Glance
- Tasks: Support quality systems and ensure compliance while driving continuous improvement.
- Company: Baxter is a healthcare leader dedicated to saving and sustaining lives since 1931.
- Benefits: Enjoy competitive pay, professional growth, and a strong work-life balance.
- Why this job: Make a meaningful impact in healthcare with a culture of collaboration and trust.
- Qualifications: 3+ years in quality roles within regulated industries; knowledge of quality systems essential.
- Other info: Flexible working hours, Monday to Friday, with opportunities for mentorship.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Be among the first 25 applicants. 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 guide us. 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, 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.
Position
The Specialist for Quality Systems will facilitate and support improvements to QMS systems through the analysis of data to ensure areas of non-conformance and opportunities for improvement are identified and addressed in a timely manner. They will manage and review the Compounding quality systems records and provide support to the Quality Associates in completing records within the quality systems. This role reports to the Quality Manager and works between 9:00 am and 5:00 pm, Monday to Friday.
Responsibilities
- Ensuring site compliance with regulations and internal procedures
- Supporting the QA Manager in management of the site Quality Management System (QMS) and Quality KPIs
- Self-identification and correction of quality issues
- Continuous improvement through CAPA and Change Control Management
- Quality disposition / risk management
- Supporting audits
- Development and approval of Standard Operating Procedures
- Investigation of deviations through non-conformance
- Approval of NCR investigations, product complaints and micro deviations
- Mentoring and coaching of new QMS record owners
Experience and Qualifications
- Minimum of 3 years\’ experience in quality team facilitation, project management, process improvement, or quality data analysis
- Minimum 3 years\’ experience in Pharmaceutical, Medical Device, Biotechnology, Chemistry, Microbiology, or related regulated industry
- Proven knowledge of Quality System processes; working knowledge of EU and UK GMP requirements (EU GMP Volume 4 Annex 1) preferred, or experience with ISO 9001, ISO 13485, MDD 93/42/EEC, or similar regulations
- Experience coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance and Complaints processes
- Experience solving problems using Root Cause Analysis techniques (e.g., 8D, GEMBA, 5 Whys, Cause and Effect)
- Internal / Lead Auditor experience
- Hands-on experience with Quality Systems software tools such as TrackWise
Benefits
- Competitive total compensation package
- Professional development opportunities
- Strong emphasis on work-life balance
- Commitment to growing and developing an inclusive and diverse workforce
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 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 you need a reasonable accommodation for any part of the application or interview process, please click the link provided in the job posting and share your request details.
Recruitment Fraud Notice
Baxter has identified incidents of employment scams where fraudulent parties pose as Baxter employees or recruiters. To learn how to protect yourself, review our Recruitment Fraud Notice.
Additional Information
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Quality Assurance
- Industries: Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Baxter International Inc. by 2x. Get notified about new Quality Assurance Specialist jobs in Stockport, England, United Kingdom.
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Specialist, QA, employer: Baxter International Inc.
Contact Detail:
Baxter International Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Specialist, QA,
✨Tip Number 1
Familiarise yourself with the specific Quality Management System (QMS) processes mentioned in the job description. Understanding how these systems operate will not only help you during interviews but also demonstrate your proactive approach to the role.
✨Tip Number 2
Brush up on your knowledge of current EU and UK GMP requirements, especially EU GMP Volume 4 Annex 1. Being well-versed in these regulations will show that you're serious about compliance and quality assurance.
✨Tip Number 3
Highlight any experience you have with Root Cause Analysis techniques like 8D or 5 Whys. Be prepared to discuss specific examples where you've successfully identified and resolved quality issues in past roles.
✨Tip Number 4
If you have experience with software tools like TrackWise, make sure to mention it. Familiarity with these tools is crucial for managing QMS processes effectively, and it can set you apart from other candidates.
We think you need these skills to ace Specialist, QA,
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Specialist, QA position. Tailor your application to highlight relevant experience in quality systems and compliance.
Highlight Relevant Experience: Emphasise your experience in quality team facilitation, project management, and quality data analysis. Use specific examples from your past roles that demonstrate your knowledge of Quality System processes and regulatory requirements.
Showcase Problem-Solving Skills: Include examples of how you've used Root Cause Analysis techniques like 8D or 5 Whys to solve quality issues. This will show your ability to identify and correct non-conformance effectively.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your skills and experiences to Baxter's mission and values. Mention your commitment to continuous improvement and how you can contribute to their Quality Management System.
How to prepare for a job interview at Baxter International Inc.
✨Understand Quality Management Systems
Make sure you have a solid grasp of Quality Management Systems (QMS) and the specific regulations that apply to the role. Familiarise yourself with EU and UK GMP requirements, as well as ISO standards relevant to the pharmaceutical and medical device industries.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss your experience with Root Cause Analysis techniques like 8D, GEMBA, and the 5 Whys. Share specific examples of how you've identified and resolved quality issues in previous roles to demonstrate your analytical skills.
✨Highlight Your Experience with Audits
Since the role involves supporting audits, be ready to talk about your experience with internal or lead auditing. Discuss any specific audits you've participated in and what you learned from those experiences.
✨Emphasise Continuous Improvement
Baxter values continuous improvement, so come prepared with examples of how you've contributed to process improvements in your past roles. Discuss any CAPA or change control management initiatives you've been involved in to show your commitment to quality enhancement.
