Description: 

1.JOB PURPOSE: To set up, operate and clean equipment in moderately complex production areas and ensure products follow appropriate procedures in a clean and safe work environment while meeting all cGMP, FDA, DEA, OSHA and other applicable regulations and troubleshoots/investigates root causes of manufacturing issues, incidents and reliability problems on the production line in order to ensure continuity of operations.

2.KEY ACCOUNTABILITIES:

Policies, Processes & Procedures:

Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner.

Day-to-day Operations:

Follows the day-to-day operations related to own job to ensure continuity of work

Job Specific Accountabilities:

• Performs line/equipment setup, cleaning and changeover activities that require the use of hand tools, removing and replacing machine parts, adjusting instrumental devices and cleaning parts in order to ensure compliance with cGMP, FDA, DEA, OSHA and other applicable regulations 
• Completes appropriate documentation to support process and production procedures including data capture, forms, logbooks, and inventory batch records
• Maintains existing and develops new tooling/fixtures and assists in writing technical reports in order to support new product introductions, validations and operator training
• Plans, coordinates, and oversees the inventory control of all raw materials to the supplier for each contract manufacturer in order to ensure orders are received properly and excess materials are accounted for
• Enters data on SAP and paper systems pertaining to manufacturing orders (MOs) and packaging standards (PSs) to ensure accurate and up-to-date information
• Troubleshoots and investigates root causes of manufacturing issues, incidents and reliability problems on the production line to ensure continuity of operations

Continuous Improvement:

Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.

Reporting:

Assists in the preparation of timely and accurate reports of the Manufacturing department to meet company and department requirements, policies and standards.

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