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Assists with coordinating quality activities to ensure project success and competitive advantage in long-term quality customer management. Responsible for preparing documentation, reviewing completed orders, interpreting customer standards, and resolving document-related issues.
The Quality Coordinator manages the generation, review, and traffic of production batch records in a cGMP environment. Responsibilities include preparing documentation for production orders, ensuring compliance with customer specifications, and performing record reviews. The role also involves facilitating product release and addressing document-related issues with customers and internal teams.
The Technical Operations Specialist is responsible for setting up, installing, and maintaining various electrical control systems and components, troubleshooting electrical defects, and ensuring proper functioning of equipment through calibration and inspection procedures.
The Manager of Quality Engineering is responsible for overseeing the Quality Engineers for the Advanced Drug Delivery segment, ensuring compliance with product specifications, managing client commitments, driving quality improvement projects, and supporting new product launches and risk management.
The Process Reliability Expeditor is responsible for expediting equipment and supplies to operations while maintaining inventory in the CMMS system. Duties include staging and inspecting tooling, collaborating with engineering on new tooling and components, delivering parts, performing cycle counts, and ensuring adherence to PCI policies and procedures.
Assists with designated execution of customer projects and ongoing order fulfillment to ensure that objectives are accomplished within the prescribed time frame and budget while adhering to applicable pharmaceutical regulations. Supports maintaining exceptional client satisfaction and superior business performance metrics.
Responsible for ensuring compliance, quality, and safety in processing customer orders. Conducts audits, reviews documentation, and drives process improvements. Performs batch record reviews, equipment evaluations, and in-process inspections. Mentors operational staff for continuous improvement. Works Friday-Sunday, 8:00am-8:00pm.
This job focuses on converting agency employees to full-time employees at PCI, contributing to operations in various departments including Quality and Warehouse.
Dedicated Continuous Improvement Engineer I responsible for leading continuous improvement activities, identifying opportunities, recommending solutions, and evaluating organizational impact. Focus on deploying continuous improvement strategy, process optimization, and implementing best practices. Requires strong understanding of lean six sigma, manufacturing processes, and data analysis.
The QA Specialist will ensure product quality and compliance by reviewing batch documentation, managing deviations and investigations, approving CAPAs, and enhancing quality systems. This role collaborates with various departments and may involve shaping GxP programs to optimize clinical and commercial product manufacturing.
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