Job Description

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Summary:
Supervise our ISO-8 controlled environment room by setting goals, organizing and assigning work, training and developing employees, and maintaining a productive, engaging work environment in order to meet established production schedules

Essential Duties and Responsibilities:

• Responsible for executing to production plan and yields within their area of production.
• Oversees training and complete training records for all manufacturing personnel.
• Responsible for ensuring that department understands and complies with quality standards and requirements as documented.
• Regularly monitors the accuracy, completeness, and timeliness of manufacturing processes.
• May act as the back up to the Manufacturing Manager as required.
• Supervises the maintenance of personnel records and timecards for staff.
• Supports the manufacturing lines to solve issues related with manufacturing processes, equipment, materials, etc.
• Develops schedules and manpower requirements for assigned areas.
• Acts as liaison between manufacturing, R&D, and engineering to get engineering requests processed correctly and in a timely manner.
• Accountable for assisting with the efficient, safe and cost-effective operation of the department; for advising and making recommendations to the Manufacturing Manager with respect to these activities.
• Coordinates with various groups such as quality and engineering to analyze product failure data and test results in order to determine causes of problems and develop solutions.
• Other duties as assigned.

• Experience in high volume manufacturing, (medical device preferred) including start-up, scale-up/scale down and in commercial setting
• Experience with process transfers, process validation, and health authority inspections
• Thorough understanding of current Good Manufacturing Practices (cGMPs) and they apply to process operation and process control
• Flexibility in working shifts to meet demand

• Bachelor\'s degree (B. A.) from four-year College or university; five years related experience and/or training; or equivalent combination of education and experience.

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