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.

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.
  
  
  

Minimum Qualifications: Bachelors’ in Manufacturing or related field OR High School Diploma

Minimum Experience: 3-5 years relevant experience in a cGMP/Manufacturing facility.

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