🚀 Supervisor, TEM Production - San Diego

Overview

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.

Responsibilities

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.

Qualifications

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.