Job Description

A medical device manufacturing client is looking to add a new full time employee onsite in Roswell, GA. This Operations Associate will perform variety of operations including, but not limited to, Receiving, Receiving Inspection, Shipping, Inventory Control, Manufacturing activities as well as environmental monitoring & maintenance. This person 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.

Must Haves:

• 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

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.

Salary of $55 - 75K annually

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