Senior Production Inventory Specialist

Enable Injections Inc.•Sharonville, OH

3d•Onsite

About The Position

This role is responsible for defining and governing the standards for ERP material transaction integrity across the manufacturing operation. The specialist will approve, reject, place on hold, or quarantine materials based on quality, traceability, or system-integrity findings. They will lead and independently resolve investigations into inventory discrepancies, determine root cause, select and implement corrective and preventive actions, and make judgments on closure criteria and effectiveness. The role involves maintaining proper labeling, segregation, and traceability of materials per medical device regulatory requirements, and owning and continuously improving the cycle count program for the Production team. Additionally, the specialist will document and report inventory variances, author and contribute to CAPA records, ensure all material transactions and records comply with quality system requirements, and support periodic physical inventory counts and audits. Daily tasks include completing material confirmations and reconciliations within the ERP/MRP system, maintaining documentation and records in accordance with Good Documentation Practices (GDP), and generating reports for material usage, scrap, and adjustments. The role requires collaboration with Production, Planning, Quality, and Warehouse teams to ensure materials are available and accurately controlled, and communication of material shortages, discrepancies, and process deviations. The specialist will identify, prioritize, and lead continuous improvement initiatives (Lean, Six Sigma, Kaizen) impacting inventory accuracy and material flow. They will also mentor and train inventory specialists and material handlers, and serve as the inventory point of contact during audits, leading or supporting corrective action plans. Other duties and business priorities will be supported as assigned.

Requirements

Associate's degree in Supply Chain, Operations, Business, or related field
Minimum 5+ years of progressive experience in material control, inventory management, or production support within an FDA-regulated manufacturing environment
Hands-on power-user experience with ERP/MRP systems; demonstrated ability to troubleshoot transaction errors, run inventory reports, and support system improvements
Deep working knowledge of GMP, GDP, FDA 21 CFR Part 820, and ISO 13485 as applied to material control and traceability
Proven ability to lead root cause analysis (RCA) and CAPA investigations for inventory discrepancies
Advanced Excel skills (pivot tables, lookups, large data sets); demonstrated ability to build and interpret inventory KPIs and dashboards
Demonstrated experience mentoring or training junior inventory / material handling staff
Strong cross-functional communication — able to influence Production, Planning, Quality, and Warehouse partners without direct authority
Demonstrated ability to exercise judgment on material disposition, process policy, and corrective action strategy
Audit-ready documentation discipline; experience supporting internal, customer, FDA, and notified-body audits
Proficient with Microsoft Office (Outlook, Word, Excel) and SAP; adaptable to new systems
Willingness and ability to work overtime as needed, including weekdays and weekends
Must be able to gown and work within a clean room and/or lab environment
Ability to lift and lower boxes of documents or handle equipment weighing up to 25 lbs

Nice To Haves

Bachelor’s degree in Supply Chain, Operations, Business, or related field
7+ years in medical device, pharmaceutical, or combination products, including direct exposure to FDA / ISO 13485 audits
Advanced SAP (MM/PP modules) or Oracle experience; familiarity with electronic batch records (EBR) and Manufacturing Execution Systems (MES). SAP strongly preferred

Responsibilities

Define and govern the standards for ERP material transaction integrity across the manufacturing operation; determine when system configuration changes, workflow modifications, or user access adjustments are required and implement or escalate accordingly
Approve, reject, place on hold, or quarantine materials based on quality, traceability, or system-integrity findings
Lead and independently resolve investigations into inventory discrepancies; determine root cause, select and implement corrective and preventive actions, and make judgments on closure criteria and effectiveness
Maintain proper labeling, segregation, and traceability of materials per medical device regulatory requirements
Own, and continuously improve the cycle count program for the Production team, including determining count frequency, methodology, location prioritization, and variance thresholds; make decisions or recommendations on schedule or process changes
Document and report inventory variances; author and contribute to CAPA records, including root cause analysis, corrective actions, and effectiveness checks
Ensure all material transactions and records comply with quality system requirements.
Support periodic physical inventory counts and audits
Complete daily material confirmations and reconciliations within the ERP/MRP system to ensure accurate production and inventory data
Maintain documentation and records in accordance with Good Documentation Practices (GDP)
Generate and maintain reports for material usage, scrap, and adjustments
Collaborate with Production, Planning, Quality, and Warehouse teams to ensure materials are available and accurately controlled
Communicate material shortages, discrepancies, and process deviations to appropriate personnel
Identify, prioritize, and lead continuous improvement initiatives (Lean, Six Sigma, Kaizen) that impact inventory accuracy and material flow; author improvement proposals, set project scope, and determine implementation approach
Mentor and train inventory specialists and material handlers on ERP transactions, cycle count procedures, and GDP standards
Serve as the inventory point of contact during internal, customer, and regulatory audits, including FDA and ISO 13485 inspections. Lead or support corrective action plans, timelines, and systemic process changes in response to audit findings
Perform other duties and support business priorities as assigned