Production Specialist I

Job Summary

The Production Specialist is responsible for managing batch records and documentation for production orders, ensuring accuracy in system entries, and supporting inventory reconciliation activities. This role will serve as a resource for floor associates, addressing issues related to Iren and the ticket system, while also assisting with tracking Work in Progress (WIP) and material inventories. Additionally, the Production Specialist will contribute to compliance and customer audits.

Key Responsibilities

• Documentation & Compliance
• Maintain batch record files in compliance with customer specifications.
• Review and close all batch records for production orders.
• Complete required paperwork according to ISO and GMP standards.
• Sign off on pharmaceutical batch records to ensure compliance.
• Inspect production records for accuracy, completeness, and professionalism.
• Document and investigate issues related to scrap, reporting causes in the scrap database.
• Production & Quality Support
• Perform quality observations of active production to confirm product specification compliance.
• Review production orders for special instructions, ensuring accuracy and completeness.
• Assist production personnel with ERP entry and resolve posting issues.
• Work with quality and engineering teams to determine root causes of scrap issues.
• Inventory Management
• Track and maintain WIP inventory of excess or orphaned materials.
• Manage partial roll inventory, ensuring FIFO (First In, First Out) practices for upcoming orders.
• Record rejected materials to the quality complaint administrator with relevant information.
• Support production supervisors with machine bin organization and material staging.
• Reconcile WIP write-off inventory as needed.
• Assist the Warehouse Supervisor with annual inventory audits.
• Reporting & Communication
• Compile daily, weekly, monthly, and year-to-date performance reports for Production Management and Plant Manager.
• Collaborate closely with customer service to address shipping quantity concerns.

This position involves approximately 80% office work and 20% time spent walking on the production floor.

Requirements

• Prerequisite Requirements
• 2 years of experience in a clerical role with document filing responsibilities.
• 1 year of experience in a manufacturing environment.
• Preferred Qualifications
• Proficiency in Microsoft Excel and Word.
• Familiarity with document organization and filing.
• Experience with internal systems, including PRM, PTS, Ticket Printing, and Iren.