Job Description

Position Overview:

This position requires performing a variety of operations for Elutia products including, but not limited to, Manufacturing activities, Shipping & Receiving, Inventory Control, as well as environmental monitoring & maintenance for a drug delivery device. The responsible individual will perform routine data entry in the MRP database, LHR releases, preparation of shipping documentation, etc. in compliance with internal procedures, FDA Quality Systems Regulations as well as ISO Standards.

Essential Duties & Responsibilities:

Manufacturing

• Issue, track and review Manufacturing Work Order (LHR) documentation for accuracy and component/product traceability.
• Manufacture, assemble products according to approved operating procedures.
• Perform label printing, initial packaging and final packaging as required to support operations functions.
• Prepare product samples for sterilization and lot release testing.
• Perform self-inspection on all assembly work performed to ensure adherence to workmanship standards.
• Maintain clean and orderly work station. · Follow all corporate, safety and production operating procedures.
• Perform environmental monitoring including viable & non-viable particulate counting, surface microbial testing as well as review and analysis of data for each test cycle.
• Other duties as required.

Inventory, Receiving, & Distribution:

• Process incoming receiving and inventory transactions in the MRP system.
• Process transactions and documentation associated with product returns.
• Perform periodic cycle counting to monitor inventory levels and report inventory balances for financial reconciliation.
• Prepare shipments with appropriate documentation in compliance with procedures and all applicable export requirements, as applicable.
• Prepare and review inspection documentation and perform inspections as needed

Education & Experience:

• High School diploma or equivalent (entry level position)
• 2+ years’ experience in manufacturing and/or quality (production, packaging, labeling incoming and shipping, critical systems, etc.) preferred.
• Experience working in regulated work environment preferred – compliance to specifications and procedures as well as FDA QSR’s (21 CFR 820) and ISO 1348

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