Specialist, QA

Overview

This is whereyour 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.

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 into Quality Manager. The role will work between the hours of 9am and 5pm, Monday – Friday.

Responsibilities

• Ensuring site compliance with regulations and internal Procedures
• Supporting the QA Manager in management of site Quality Management System(QMS) and Quality Key Performance Indicators (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.

ExperienceRequired

• Minimum of 3 yrs experience in quality team facilitation, project management, process improvement or quality data analysis role.
• Minimum 3 yrs experience in Pharmaceutical, Medical Device, Biotechnology, Chemistry, Microbiology or other related regulated industry.
• Proven knowledge of Quality System processes (essential), with working knowledge of current EU and UK GMP requirements (EU GMP Volume 4 Annex 1) (preferred), or experience of working within ISO 9001, ISO 13485, MDD 93/42/EEC, or similar regulations and standards (considered).
• Experience of coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance and Complaints processes (required).
• Experience of problem solving using Root Cause Analysis techniques such as 8D, GEMBA, 5 Whys, Cause and Effect (required).
• Internal / Lead Auditor experience.
• Working knowledge and hands on experience of software tools to manage Quality Systems processes such as TrackWise (required).

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

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

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.

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