Supervisor, TEM Production - San Diego at Werfen

Position Summary:

The TEM Production Supervisor is responsible for daily production and inventory management ensuring goals are met, quality, production, efficiency, and timely delivery of existing and new/modified products to stock. The TEM Production Supervisor is also responsible for leading department staff in support of manufacturing activities.

This is a 3rd shift role, from 9:30 pm-6 am. The salary range for this position is currently $80,000- $100,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Key Accountabilities

Essential Functions:

• Execute assigned weekly production plan as per weekly schedule. 
• Ensure all department work is done in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). 
• Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. 
• Manage inventory to insure quality, production, and efficiency. 
• Maintain adequate staffing needs in support of business objectives; work to avoid overtime hours, achieve assigned production goals, meet unscheduled peaks in workload, ensure timely release of product, and to avoid back orders.  Coordinate qualification and validation trials. 
• In accordance with company policy, process and approve staff work hours in companys time-clock system; approve time off requests ensuring business needs are continually met. 
• Maintain effective manufacturing and control of products in compliance with all established manufacturing specifications and control procedures. 
• Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department performance. 
• Oversee maintenance of department training records. 
• Identify and address staffing needs with management. 
• Continually evaluate performance of direct reports; take appropriate disciplinary action in accordance with company policy as necessary. 
• Ensure safe working conditions throughout the department at all times ensuring adherence to all safety policies and procedures; work with management to identify and address safety matters and concerns. 
• Ensure support for the transfer of technology (product) to routine manufacturing; evaluate new technologies and the pilot work that is required to assure minimum problems with initial and subsequent manufacturing. 
• Manage special projects as assigned by management. 
• Ensure accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. 
• Identify production and manufacturing issues and work to implement corrective action. 
• Work cross-functionally to coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints. 
• Ensure and maintain compliance with the Companys quality system requirements through training and adherence to policies, procedures and processes. 
• Other duties as assigned.

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent; additional training/education a plus. 
• Minimum of five (5) years previous related manufacturing supervisory experience within a regulated medical device manufacturing or pharmaceutical environment. 
• Previous lead or supervisory experience, including experience with staffing and time management. 
• Knowledge of lean manufacturing principles preferred. 
• Demonstrated ability to support business goals and objectives related to cost and manufacturing processes. 
• Understanding of coagulation-based manufacturing processes and company products. 
• Good understanding of GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO. 
• Working knowledge of Microsoft Office and experience with large Enterprise Resources Planning (ERP) system. 
• Good written and verbal communication. 
• Ability to work as part of a team. 
• Ability to identify and correct problems. 
• Good leadership abilities.