CAPA Quality Analyst

Baxter
Milwaukee, WI Full Time
POSTED ON 8/26/2024 CLOSED ON 10/5/2024

What are the responsibilities and job description for the CAPA Quality Analyst position at Baxter?

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

This is where your creativity addresses challenges!

As the Quality Systems Specialist responsible for the Corrective and Preventive Action (CAPA) program, you will review all phases (investigations, action planning, verification of effectiveness, etc.) and provide/request information, where required, to ensure complete and thorough CAPAs.

Your Team

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.

What You'll Be Doing

  • Facilitate site Corrective Action Board (CAB) meetings.

  • Develop site CAB presentations and maintain meeting minutes.

  • Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events.

  • Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.

  • Escalate issues to senior management in a timely manner.

  • Monitor investigations and approvals to ensure that all required information is captured and documented with relation to events.

  • Provide training to employees working with CAPAs and Nonconformance Evaluations (NCEs).

  • Participate in external and internal regulatory compliance inspections.

  • Maintain CAPA log for accurate and up-to-date status of CAPAs.

  • Perform monthly metrics, as required (Quarterly review, Global Scorecard, etc.).

  • Present site CAPA information at Global CAB meetings & CAPA Analyst meetings.

  • Provide direction to NCE owners to achieve completion.

  • Recommend NCE/CAPA system process improvements.

What You'll Bring

  • Minimum of an Associates degree.

  • Minimum 1 year experience working in Quality Systems, preferably with CAPAs.

  • Understanding of industry requirements relating to CAPA.

  • Excellent verbal and written communication skills, including attention to detail, questioning, and listening skills, to understand the impact on other areas

  • Organizational skills and ability to plan and implement resolutions to problems.

  • Ability to communicate between various organizations and work with multi-functional teams.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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 $76,000 - $104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

#LI-LS1

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

144894

Qualifications:

7900 N. 86th Street|Milwaukee, WI 53224|United States of America

Salary : $76,000 - $104,500

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