Quality Systems Associate

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Quality Assurance Associate Thetford

Full-time On-site Core hours between 07:0017:30 with flexible working within this window

Are you meticulous analytical and passionate about producing highquality documentation that drives compliance and operational excellence Were looking for a Quality Assurance Associate to join our Compounding Unit in Thetford someone who thrives in a regulated environment and brings strong technical writing and data analysis experience to the table. Our compounding department manufactures aseptic products such as chemo-therapy antibiotics and nutrition.

This role is critical to maintaining the highest standards of GMP and Specials manufacturing compliance and is fully on-site due to the handson nature of our operations.

What youll be doing

In this role youll play a vital part in ensuring our facility operates safely compliantly and in line with regulatory and corporate expectations. Key responsibilities include:

• Ensuring continuous compliance of the Compounding Unit with cGMP Specials manufacturing requirements local procedures and Baxter Corporate policies.
• Leading and executing highquality documentation reviews with strong technical writing accuracy.
• Analysing complaint data monitoring trends and managing CAPAs to drive effective solutions.
• Supporting thorough timely investigations for deviations complaints and nonconformances.
• Ensuring all Quality System and GMP commitments are completed within required timelines.
• Supporting preparation and development of Annual Product Quality Reviews including data collation and analysis.
• Contributing to validation activities and change control processes.
• Proactively identifying continuous improvement opportunities within Quality Systems QA and Operations.
• Communicating significant GMP or product quality issues to QA Management promptly.
• Ensuring full compliance with EHS GMP GDP corporate policies and external regulatory requirements.
• Conducting and participating in Gemba activities identifying compliance gaps and supporting implementation of corrective actions.

What youll bring

This role requires strong technical writing and analytical skills these are essential. Were looking for someone who can interpret data write clearly and concisely and produce documentation that stands up to regulatory scrutiny.

You will also bring:

• Experience in a GMP or regulated manufacturing environment (pharmaceutical experience idea but not essentiall).
• Confidence in reviewing complex data sets and producing accurate highquality reports.
• Excellent attention to detail and a proactive approach to identifying issues and improvements.
• Strong communication skills and the ability to challenge appropriately in support of compliance.
• A collaborative mindset with the ability to work effectively with Operations Quality Systems and wider teams.

Why join us

At Baxter every role contributes to improving the lives of patients worldwide. Youll work with a dedicated team gain exposure to a broad range of quality activities and have opportunities to grow your career while making a real impact.

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

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