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- Tasks: Support and improve Quality Management Systems in a regulated environment.
- Company: Baxter Compounding, a leader in the pharmaceutical and medical device industries.
- Benefits: Competitive salary, professional development, health benefits, and paid time off.
- Why this job: Join a dynamic team making a real impact on quality and compliance.
- Qualifications: Experience in Quality Management Systems and strong analytical skills required.
- Other info: Flexible working with opportunities for travel and career growth.
The predicted salary is between 36000 - 60000 £ per year.
Baxter Compounding is recruiting an enthusiastic individual with hands-on experience in implementing changes within a regulated Quality Management System environment, such as the Pharmaceutical or Medical Device industries. The role involves collaborating with Quality and Operational teams across Baxter Compounding sites in the UK, Ireland and Sweden to maintain, improve and ensure compliance of the Quality Management System. The role reports to the Quality Systems Manager (UK, Ireland and Nordics) and is nominally based at a compounding site with some home working and travel within the UK, Ireland and Sweden as required.
Responsibilities
- Quality Management Review (QMR): Support scheduled completion of QMRs across the UK, Ireland and Nordic network through trending and reporting of applicable QMS data; track and report performance metrics to identify opportunities for improvement; support timely completion of actions arising from QMR.
- Audit Management: Maintain and communicate the annual Internal Audit schedule and Auditor Training Matrix; track, trend and analyse audit findings and NCRs in TrackWise with cross-site collaboration; initiate corrective and preventive actions and ensure timely closure; support Internal, Corporate, external Regulatory and Customer audits and update the QMS accordingly.
- Complaints: Progress Complaints in TrackWise with assigned Owners to ensure timely risk assessment and closure; trend, monitor and report Complaints data to support QMR and cross-site improvement; update local Complaint Management procedures in line with Corporate, Compounding and Regulatory requirements.
- Nonconformance and Corrective & Preventive Action (CAPA) Processes: Initiate, investigate, assess risk and progress NCR/CAPA/CPI/OOL/SCAR; trend and report NCR/CAPA/CPI/OOL/SCARs to support QMR and cross-site improvement; maintain local Non-Conformance and CAPA procedures in line with Corporate, Compounding and Regulatory requirements.
- Change Control: Maintain an effective change control process; trend, monitor and analyse Change Control metrics; generate and maintain impact assessment tools, workflows and procedures; ensure all impacted products, processes and sites are evaluated and approved before initiating a change; track progress to ensure timely completion.
- General Responsibilities: Support the Quality Policy, business goals and objectives; contribute to country/local initiatives and projects; assist in development and delivery of QMS training; identify changes to processes and systems to improve efficiency while maintaining compliance; adhere to Environmental Health & Safety policies and requirements.
Qualifications
- Extensive experience supporting, improving and maintaining Quality Management Systems in a regulated environment, with working knowledge of EU/UK GMP requirements (EU GMP Annex 1) preferred.
- Strong analytical and problem-solving skills, with experience in Root Cause Analysis and critical thinking.
- Experience in Risk Management including analysis of product, process and system risks.
- Hands-on experience with software tools to manage Quality System processes (TrackWise, Agile, MasterControl, QPulse beneficial).
- Strong presentation, communication and negotiation skills; ability to work with all levels of the organization.
- Approximately 20% travel to compounding sites within the network may be required.
- Fluent in written and spoken English.
Benefits
- Support for Parents
- Continuing Education / Professional Development
- Employee Health & Well-Being Benefits
- Paid Time Off
- 2 Days a Year to Volunteer; Competitive total compensation package
- Professional development opportunities
- High importance placed on work-life balance; diverse, global environment across 100+ countries
Associate, QS in Stockport employer: Baxter
Contact Detail:
Baxter Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate, QS in Stockport
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Baxter Compounding. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by practising common questions related to Quality Management Systems. We all know how important it is to show off your analytical skills and problem-solving abilities, so be ready to share examples from your experience.
✨Tip Number 3
Show your enthusiasm! When you get the chance to speak with someone from Baxter, let them know why you're excited about the role and how you can contribute to their Quality Management System. Passion goes a long way!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Associate, QS in Stockport
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate, QS role. Highlight your hands-on experience in Quality Management Systems and any relevant skills that match the job description. We want to see how you can bring value to our team!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management and how your background aligns with our needs. Keep it engaging and personal – we love a bit of personality!
Showcase Your Achievements: When detailing your experience, focus on specific achievements rather than just duties. Use metrics or examples to demonstrate how you've improved processes or compliance in previous roles. We appreciate results-driven candidates!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Let’s get you on board!
How to prepare for a job interview at Baxter
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of Quality Management Systems, especially in regulated environments like pharmaceuticals or medical devices. Be ready to discuss your hands-on experience and how you've implemented changes in these systems.
✨Showcase Your Analytical Skills
Prepare to demonstrate your analytical and problem-solving skills. Think of specific examples where you've used Root Cause Analysis or tackled complex issues. This will show that you can think critically and contribute to improving the Quality Management System.
✨Familiarise Yourself with Relevant Software
If you have experience with software tools like TrackWise or Agile, be sure to mention it. Familiarity with these tools is a big plus, so consider discussing how you've used them to manage Quality System processes effectively.
✨Communicate Effectively
Since the role involves collaboration across teams, practice your communication skills. Be prepared to explain how you've successfully worked with different levels of an organisation and how you can contribute to maintaining compliance and improving processes.
