Production Flow Architect — cGMP, ERP & Batch Records

Threshold Enterprises, Ltd; Scotts Valley (CA); Vor Ort; USD 28.000 - 34.000; Vollzeit

Zusammenfassung

Threshold Enterprises, Ltd in Scotts Valley, CA is seeking a manufacturing support professional to help expedite work orders, manage raw materials, and ensure compliant batch records. You will collaborate with Manufacturing Planning & Production, Pilot, R&D, Purchasing and Quality to maintain manufacturing flow and accuracy.

The role emphasizes cGMP/FDA compliant documentation, ERP system usage, and cross-departmental coordination, with exposure to Navision, RedZone, and AFP planning tools.

Qualifikationen

• Production/planning experience.
• Knowledge of Excel and ERP applications.
• Ability to learn Navision, RedZone and AFP production planning systems.
• Fluent in English and good cross-departmental communications skills.
• Experience with Microsoft Office and related applications.
• Available to work overtime and weekends.

Aufgaben

• Create and manage cGMP/FDA compliant batch records and MMRs through review for Production.
• Check production orders for accuracy, format, run size, priority, and inventory.
• Coordinate with Pilot, R&D, Planning, and Quality to ensure compliant batch records.
• Check lots for deviated materials, adjust batches, and maintain deviation database.
• Generate deviations for materials and manage inventory for shortages and expiration.
• Perform other duties as assigned by Threshold management.
• Develop product rework MMRs with Pilot, MFG, and Quality.

Kenntnisse

Production planning

Excel

ERP systems

Navision

RedZone

English fluency

Cross-departmental communication

Overtime weekends

Tools

Navision ERP

RedZone

AFP production planning

Jobbeschreibung

Threshold Enterprises, Ltd in Scotts Valley, CA is seeking a manufacturing support professional to help expedite work orders, manage raw materials, and ensure compliant batch records. You will collaborate with Manufacturing Planning & Production, Pilot, R&D, Purchasing and Quality to maintain manufacturing flow and accuracy.

The role emphasizes cGMP/FDA compliant documentation, ERP system usage, and cross-departmental coordination, with exposure to Navision, RedZone, and AFP planning tools.