Job description:
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.
