Quality Assoc III
Round Lake, IL
Req ID 48642BR
Business Title
Quality Assoc III
Business
Global Quality
Sub-Business
Global Compliance
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Perform re-evaluations of Baxter's suppliers using performance data (Supplier Corrective Action Reports (SCAR), audits, procedural requirements)
Support on-site audits and review of 3 rd party (SQA Services) audit reports and correction action responses. Ability to travel up to 35% including internationally.
Utilizes the Global Supplier Quality Trackwise System (GSQTS) for maintaining Supplier Quality Records
Identifies Baxter supplier compliance issues; helps to resolve issues in a timely manner.
Partners with facilities, divisions, and regions to ensure successful implementation and compliance to CQP / regulations.
Own and resolve supplier related CAPA(s). Analyze supplier related defect data to determine root cause
Understands and assures conformance to regulations for Drug and Biologic suppliers.
Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
Interacts frequently with subordinate supervisors and functional peer group managers
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
Job Requirements
•Experience within drug/biologic manufacturing and quality operations
•Experience in launching new medical products
•Thorough knowledge of applicable procedures, specifications, regulations and standards.
•Strong technical, analytical and problem solving skills.
•Excellent verbal and written communication skills
•Good interpersonal/communication/influencing/negotiation skills.
•Ability to respond to customers (Internal and External) in a timely manner
•Ability to build relationships across functional boundaries at multiple levels internally and externally
•Bachelors Degree in science or engineering required
•Advanced degree in the life sciences, physical sciences or engineering is ideal
•Minimum of 5+ years of experience in Quality, or related field in the medical products industry
•Strong technical writing skills. Must be able to clearly document audit findings within audit reports.
•Actively demonstrates Baxter's leadership expectations.
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.
