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Deliver on quality or CAPA initiatives using technical knowledge, critical thinking skills, and intelligent risk skills. As a Senior Principal Electrical Engineer, you will be responsible for providing key technical expertise and some leadership within the Mechanical Circulatory Support (MCS) Engineering organization.
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Train Suppliers to effectively execute Supplier Corrective Action Requests (SCAR) and Corrective Actions Preventive Actions (CAPA). Responsible for driving the Corrective Action and Preventive Action (CAPA) process.
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Experienced knowledge and implement the following: Design and Process FMEA's (Failure Mode Effects Analysis), CAPA (Corrective and Preventive Actions) process, NPI (New Product Introduction) process - Design Transfer, V&V, Complaints Handling process and Change Control process.
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Root Cause Investigation / CAPA. Supplier Quality Engineer II (12 month contract. Lead PPAP execution with supplier and ensure robust supplier process qualification / validation through IQ, OQ & PQ methodology.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Review and approve complaint, CAPA, NCs, Supplier CAPAs, and Audit Observation investigations. Review and approve complaint, CAPA, NCs, Supplier CAPAs, and Audit Observation investigations. Perform supplier quality assessments and collaborate with suppliers to improve product quality.
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Assure appropriate CAPA are implemented and tracked as part of the deviations/investigations. BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering, etc.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Collaborate with CAPA system item owners and cross-functional teams to ensure they are correctly, clearly, and completely documented in compliance with procedural and technical writing requirements.
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Manages Change Management, Deviation/Investigation/CAPA and Customer Complaint systems to ensure compliance with site procedures and agency requirements. A minimum of 5 years of experience in the pharmaceutical industry with manufacturing and/or quality assurance experience in the pharmaceutical manufacturing.
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Manufacturing responsibilities including master record, training, process controls, labeling, change control, and CAPA. Responsible for all site quality metrics and reporting for monthly and quarterly business reviews - e.g., Product Complaint rates, Cost of Poor Quality, CAPA, etc.
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Ensures raw materials and packaging components material/supplier qualifications are performed in accordance with product NDA requirements and with proper protocol execution and change control. Manages function of the Quality Unit responsible for documentation administration, change management program, deviation and customer complaint systems, packaging component life-cycle process (artwork/package engineering/specification development) supporting technical and quality operations.
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Provide guidance and support to departments across the organization on quality-related matters, including document control, training, and CAPA (Corrective and Preventive Action) processes. The Sr Director of Quality Management and Auditing will be responsible for overseeing the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with FDA (Food and Drug Administration), CBER (Center for Biologics Evaluation and Research), and CDER (Center for Drug Evaluation and Research) regulations and guidelines.
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Degrees: High School,Cert,GED,Trn,Exper Licenses & Certifications: Certified Accounts Payable Associate NAPCP Certified Purchasing Card Professional Additional Qualifications: Certified Accounts Payable Associate (CAPA) or Certified Purchasing Card Professional (CPCP) required.
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Lead quality improvement projects and teams to improve quality and operational processes as a result of opportunities identified through CAPA program, accreditation survey findings, quality assurance, internal audits, and activities related to the CarelonRx pharmacy strategy.
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