Manufacturing Planner – Batch Records & Compliance

Threshold-Enterprise; Scotts Valley (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Threshold-Enterprise in Scotts Valley, CA, is seeking a production planning professional to accelerate the flow of quality work orders into manufacturing. You will manage raw materials, create and review cGMP/FDA compliant batch records and MMRs, and ensure accuracy of production orders and formats.

You will collaborate with Pilot, R&D, Planning and Quality to maintain compliant batch records, check deviations, and generate additional records as needed.

Qualifications

• Production/planning experience is required.
• Proficiency with Excel and ERP applications is essential.
• Ability to learn Navision, RedZone and AFP production planning systems.
• Fluent in English and able to communicate across departments.
• Experience with Microsoft Office and related applications.
• Willing to work overtime and weekends.

Responsibilities

• Expedite the flow of quality work orders into manufacturing.
• Manage raw materials and associated inventory.
• Create and manage cGMP/FDA compliant batch records/MMRs.
• Check production orders for accuracy, format, run size, and priority.
• Coordinate with Pilot, R&D, Planning, Quality to ensure compliant batch records.
• Check lots for deviated materials and adjust batches; maintain deviation database.
• Generate deviations as needed for materials and manage shortages/expiration dates.
• Perform other duties as assigned by Threshold management.

Skills

Production planning

Excel

ERP systems

Cross-functional communication

Attention to detail

Math skills

Problem solving

Tools

Navision

RedZone

Intellect

AFP production planning

Microsoft Excel

ERP systems

Job description

Threshold-Enterprise in Scotts Valley, CA, is seeking a production planning professional to accelerate the flow of quality work orders into manufacturing. You will manage raw materials, create and review cGMP/FDA compliant batch records and MMRs, and ensure accuracy of production orders and formats.

You will collaborate with Pilot, R&D, Planning and Quality to maintain compliant batch records, check deviations, and generate additional records as needed.