Position Summary

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Job description

The primary purpose of this position is to prepare Vitek susceptibility and identification media and/or subcomponents, dispensing system setup/verifications, ensuring timely delivery of high-quality product to Card production, prepare Clean-In-Place solutions, being current on training including curriculum procedures, workstation organization and cleaning, establishing a safe work environment, housekeeping and maintenance functions in the production department.

Primary Duties

Perform all work in the Production Department in a safe manner in accordance with the company policy and/or procedure.

Perform and document complex manufacturing steps and verification as described in company procedures\policies for the following, but not limited to:

Ensure Media and/or subcomponent preparation is completed with a high level of accuracy in a timely manner for prompt product delivery based on production schedule.

Filtrations – including checks to ensure that all filters are functioning properly and per procedure.

Verify that all media is appropriately labeled, manufactured, and stored based on all regulatory and Master Formulary specifications.

Proper Equipment (steam kettles, etc.) operation and Clean-In-Place (CIP) operation.

Media dispense setup with a high level of speed and accuracy (setting the pump dispense volume, placing the dispense head and verifying connections and bag numbering).

Assist with end of lot documentation review for Device History Record - Master Formulary, etc. All documentation practices are to follow all appropriate procedures\policies.

Report scheduling or availability issues with product planned for manufacture in MES to management or scheduler. Remain flexible into abrupt changes in day to day due to unplanned changes.

Inspect and ensure all equipment is calibrated and in working order before performing any manufacturing task. Management of any items found in need of repair immediately to prevent production delays. Perform start up and shut down procedures for the Lab equipment as described in company procedures\policies.

Maintain adequate inventories of general lab supply and inform department’s designated purchasing resource when additional items are required.

Maintain FEFO for all long-term stocks, broths and chemical components.

Participate in new product development and assist with new product transition to production from R&D and Industrialization as required.

Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Perform all work in compliance with company quality procedures and standards.

Perform other duties as assigned.

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