Quality - Quality Associate III
Perform re-evaluations of Baxters suppliers using performance data (Supplier Corrective Action Reports (SCAR), audits, procedural requirements) Support review of 3rd party (SQA Services) audit reports and correction action responses. 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. Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 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 Education and/or Experience: BS in science or technical discipline preferred. 3+ years experience in Quality, Manufacturing, Chemistry, Biology, or related field which should include 1-2 years of supervisory experience. Strong technical writing skills. Must be able to clearly document audit findings within audit reports. Actively demonstrates Baxter's leadership expectations. also required.
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Round Lake, Il
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Expired |
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