Schedules, plans and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts internal assessments and compliance gap analysis using the applicable quality manual, division and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements. Supports management during external inspections and participates in the coordination and management of external inspections as required. Schedules and Coordinates Management Review and Quality Data Review meetings, including summaries of the data presented, conclusions, and meeting minutes. Prepares and publishes annual product reviews.
• 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. Elevates 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.
• Supports management during external inspections and participates in the management of external inspections as required. Tracks and reports on commitment status through closure.
• Schedules and coordinates Management Review and Quality Data Review meetings, including 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 regulatory 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 literature
• 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 strong team player with good problems solving, and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• BS in business/science or equivalent degree. 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry
Internal Number: 18000A0Q
About Baxter Healthcare Corporation
Baxter employees are united in a mission to save and sustain lives. We are passionate about meeting the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies, and about making a meaningful difference in our communities.