Operations Associate

Essential Duties & Responsibilities

Production

• 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 13485