Quality Compliance Associate

3 weeks ago

Round Lake, United States BAXTER Full time

**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.

**Your Role at Baxter**

The Quality Compliance Associate schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Will conduct internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements.

This role supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required and also schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes. Prepares and publishes annual product reviews and is responsible for ensuring site is ready for regulatory inspections.

**Your Team at Baxter**:
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

**What you'll be doing**:

- Execution and management of the internal audit process at Round Lake Drug Delivery and Penicillin facility ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to the site operations.
- Schedule and plan for the audit activity by researching background information, including previous audit results. Plan and develop assessment strategies and logistics
- Perform internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management.
- Evaluate corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Raise issues to management as appropriate. Track and report on commitment status through closure. Work with plant partners to ensure audit commitments are completed according to the approved timeliness targets.
- Manage the audit file through the entire process to closure. Prepare summary reports depicting results and trends for management review purposes. Ensure plant collaborators provide data in a timely manner. Ensure data is submitted on time into the MOST system for corporate level management reviews.
- Perform follow-up audits, when applicable, to confirm corrective and preventive action is effective
- Train and mentor new auditors and lead the guest auditor program. Maintain the training curriculum for auditors.
- Work with customers for services provided by Baxter Round Lake Drug Delivery. Ensure customer concerns are addressed in a timely manner
- Support management of external inspections. Track and report the status of external commitments through closure
- Ensures Quality Agreements or Distribution Agreements are maintained and facilitates any updates to agreements

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