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Summary of Position

The role of a Manufacturing Technician is to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands. The Manufacturing Technician will have advanced knowledge of the manufacturing process and serve as one of several lead technicians while coordinating work within the standard operating procedures (SOP's).

Essential Functions

• Ensure strict adherence to quality, safety, regulatory and written procedures in the manufacture of products in accordance with OSHA and CFR (cGMP) guidelines.
• Ensure vigilance to the production schedule to meet customer demands and reduce overtime (ensure most effective and efficient use of personnel, materials, and time).
• Demonstrates a willingness to be flexible and adaptable to the needs of the department and business.
• Takes ownership and is an active member with continuous improvement activities including: reliability team meetings, root cause analysis, SOP and Batch record improvements, Kaizen events, and Customer Complaints.
• Ensure the maintenance and cleanliness of department, premises, and equipment.
• Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines. Review documentation, make corrections, and sign off as required by SOPs and cGMP Guidelines.
• Monitor product quality to ensure compliance with standards and specifications.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
• Inspect in-process and finished products for quality and adherence to customer specifications.
• Ability to identify and verify appropriate materials, area conditions, process for production and address any abnormalities in the process, with materials or in area conditions in collaboration with Quality and leadership.
• Take full ownership and accountability of equipment, process and area assigned to or related to production process.
• Use logical methods to solve difficult problems with effective solutions and is able to makes sound decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick quality decision.

Requirements

• College degree focused in chemistry, biology, or biotechnology preferred, Associate level degree, technical certification or commensurate experience will be considered.
• 1+ years of relevant work experience required in a regulated manufacturing environment.
• Able to provide front line troubleshooting of equipment/process issues.
• Thorough understanding of the needs of internal/external customers and ensuring customer satisfaction a top priority.
• Knowledge of Good Manufacturing Practices c(GMP)'s and applicable Quality System Standards.

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