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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- 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
Preferred:
- 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
Skills & Competencies:
- 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
Physical Requirements:
- 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
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
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