Quality Associate II

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 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.

Your role at Baxter

Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts 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. Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.

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.

What you'll be doing

* Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter's Quality System, and the regulations and standards applicable to RLDD operations.

* Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics.

* Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management.

* Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure.

* Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes.

* Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective.

* Trains and mentors new auditors and manages the guest auditor program.

* Supports management of external inspections. Tracks and reports the status of external commitments through closure.

* Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure.

* Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects.

* Remains current in regulatory trends and requirements through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet, or other industry literature

What you'll bring

* BS in business/science or equivalent degree.

* 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry

* Previous auditing experience required, and ASQ and/or other accreditation is highly desirable.

* Strong interpersonal skills and great attention to detail are necessary.

* Must be a team player with good problem solving, and good verbal and written communication skills.

* Must be able to handle multiple projects concurrently.

* Computer skills/experience using MS Office, Track Wise, Cornerstone, or similar systems is highly desirable.

* Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

* Knowledge of and experience with outside the US regulatory requirements is desirable.

* A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated range is meant to reflect an anticipated salary range…