CAPA Quality Analyst

$76,000 - $104,500/Yr

Baxter International - Milwaukee, WI

Full-time - Entry Level

Milwaukee, WI

Miscellaneous Manufacturing

About the position

At Baxter, we are deeply connected by our mission to save and sustain lives. As a CAPA Quality Analyst, you will play a crucial role in the Corrective and Preventive Action (CAPA) program, ensuring that all phases of CAPA processes are thoroughly reviewed and executed. This includes investigations, action planning, and verification of effectiveness. Your work will directly impact the quality of products that are shipped worldwide, making a positive difference in the lives of patients. You will be part of a team that values creativity and collaboration, where every role contributes to the overall mission of the company. The Quality function at Baxter is dedicated to maintaining high standards, and you will have the opportunity to influence quality decisions that prioritize patient safety above all else. In this role, you will facilitate site Corrective Action Board (CAB) meetings, develop presentations, and maintain meeting minutes. You will engage with CAPA owners to drive the completion of investigations and root-cause analyses, ensuring that all necessary information is documented. Your analytical skills will be essential as you monitor trends and the effectiveness of the CAPA process, driving improvements where needed. You will also provide training to employees on CAPAs and Nonconformance Evaluations (NCEs), participate in regulatory compliance inspections, and maintain an accurate CAPA log. Your contributions will be vital in presenting CAPA information at global meetings and recommending process improvements to enhance the CAPA system.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Equitable pay practices
• Discretionary bonuses
• Flexible workplace policy allowing a minimum of 3 days a week onsite