Sr. QMS Lead Auditor
Vernon Hills, IL
Req ID 50798BR
Business Title
Sr. QMS Lead Auditor
Business
Global Information Technology
Sub-Business
Global Functions
Country
US
State/Province
Illinois
Location of Position
Vernon Hills, IL
Shift_
1st
Job Description
•Participates and supports external inspections conducted by Baxter entities (Corporate Audit, Global Compliance) and outside regulatory agency including FDA, EMA, Health Canada, TUV, etc., (CQM07 - Management Control: External Inspections)
•Provides leadership and performs Internal Audits for Global IT as a Baxter certified auditor (CQM07 - Management Control: Internal Audits)
•Leads / Performs supplier audits as a Baxter certified auditor (CQM03 - Materials / Supplier / Purchasing Control)
•Metrics reporting and analysis for Management Review (CQM07 - Monitoring and Improvement)
•Evaluates corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevates issues to management and monitors extended corrective actions, as appropriate.
•Manages the assessment file through the process to closure.
•Remains current in regulatory trends through attendance at related conferences, seminars, meetings and other training methods such as independent study of periodicals, Internet or other literature. Applies this knowledge by training new auditors.
•Prepares management reports depicting trends and useful data for management review purposes.
•Supports management during external inspections and participates in the management of external inspections as required.
Job Requirements
Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable an independent assessment of risk. Good understanding of business concepts and knowledge of industry technologies. Experience in all stages of IT systems development and support. Expertise in GxP regulations and quality management systems. Excellent interpersonal skills. Resourceful, self-reliant, self-motivated and confident. Able to work independently and be flexible to changing priorities. Strong personal computer skills. Must have excellent teamwork and organizational skills.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
