OPERATIONS MANAGER
Larry Radzely
Job Details Education & Requirements:
- Bachelor's degree from a four-year college or university required (Business, Supply Chain/Logistics, or Sciences).
- Minimum of 4-5 years of managerial or supervisory experience required.
- Strongly preferred: knowledge of ISO 13485, cGMP, and FDA regulations within the IVD industry, as well as experience in reagent/chemical manufacturing (or a similar industry) and supply chain/logistics.
- NOTE: No relocation, need to reside in New Jersey within a one hour drive of Parsippany NJ.
- Recruit, train, and oversee staff while managing daily operations, including manufacturing scheduling, procurement, receiving, shipping, and equipment utilization.
- Ensure all processes, documentation, and batch records meet ISO 13485 and FDA requirements, while supporting audit readiness for internal and external reviews and leading CAPA (Corrective and Preventive Action) activities.
- Manage and monitor KPIs: OTIF, throughput, customer satisfaction, supplier survey and present findings to leadership.
- Develop methods to analyze performance in supply chain and customer service areas and provide actionable solutions.
- Collaborate with the finance team to review and refine inventory accuracy and product standard costs, ensuring that cost of goods and profit margins align with company objectives.
- Oversee a comprehensive equipment maintenance program, including calibration, preventive maintenance (PM), and ensuring the availability of required spare parts.
- Develop and manage Operational KPIs for the business.
- Develop and update SOPs to cGMP
- Provide accurate and timely reports for related business units (customers, management, finance, RAQA)
Vacancy posted 3 days ago
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