Production Team Leader (1st and second shift)

Job Title:

Production Team Leader (1st and second shift)

Department:

Manufacturing Indirect

Reports To:

Production Manager

Pay Classification:

Non-Exempt

Position Summary:

Responsible for the direct supervision (training and performance management) of all Production staff, including the execution of day-to-day activities related to the application of reagents and production of cards. Responsibilities include ensuring the manufacturing schedule is met in order to meet production targets in accordance with cGMP/quality requirements and standards. as well as developing, updating, and implementing policies and procedures under the guidance of the Production Manager.

Duties & Responsibilities include but are not limited to:
  • Supervise all operations involved in the production of cards for all Chembio diagnostic products, which includes training, retention and performance development of Production personnel through hands-on training, demonstration, and competency skills assessment
  • Planning and execution of assigned work established by the Planning department. Allocate resources accordingly to assure work is conducted in compliance with manufacturing batch records / quality system requirements, including manufacturing standards.
  • Establishment and improvement of procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
  • Ensure consistent execution according to batch records, and that all Production operations are performed according to established SOPs.
  • Work on the manufacturing floor as needed to provide direction, oversight on processes being completed, and aid in the completion of tasks required to meet the needs of the Manufacturing schedule.
  • Communicate with the VP of Operations and Production Planner regarding any nonconformances that arise during processing that will impact scheduled product or delivery dates.
  • Coordination with the Formulations Lab Team Leader to ensure the correct quantity and quality of material is received for application at specified time points.
  • Direct collaboration with the Facilities & Maintenance Manager on all preventative and unscheduled maintenance of equipment performed in the area, in addition to adjustments made to ensure required environmental conditions are met
  • Identify, recommend and implement changes to improve productivity, line efficiency, and reduce cost and down time. Investigating and correcting variances in labor and equipment efficiency standards.
  • Participate in root-cause investigations related to product problems, lot failures and yield discrepancies and recommending corrective and preventative actions.
  • Assists R&D and Regulatory in product transfers, design control, risk management, and RIR investigations.
Skill Sets:
  • Acts with sense of urgency
  • Confident in abilities to elevate issues to the Sr. Leadership Team /Manager while also offering solutions
  • Troubleshooting of issues that arise during processing
  • Able to provide hands-on training with a high degree of understanding and skill
  • Communication with employees & manufacturing support personnel
  • Motivation of employees while providing leadership
  • Ability to assess skill and proficiency level of each employee for required processes
Qualifications Required:
  • Bachelors degree or higher in a science related field preferred.
  • Experience in manufacturing of diagnostic testing devices, experience with current Good Manufacturing Practices (cGMP) and relevant International Standards Organization (ISO) requirements.
  • Experience with Microsoft Office applications and Visual.
  • Excellent verbal and written communications skills, as well as strong technical leadership skills are required.
  • Knowledge of GMP’s, ISO and FDA guidelines related to industry.
  • Familiar with OSHA compliance procedures.
  • Willingness to work on flexible days/hours.

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.