Production Department Manager

Job Title:                      Manager – Production Department

Department:                 Operations

Reports To:                  Director of Manufacturing

Pay Classification:       Exempt

Position Summary:      Manages the day-to-day activities related to the application of reagents and production of test strips for Chembio Rapid Diagnostic Tests, including the direct supervision (training and performance management) of all Production supervisors and manufacturing staff. Responsibilities include developing and implementing policies and procedures, assuring an orderly and streamlined workflow, and building a team atmosphere.

Duties & Responsibilities include but are not limited to:

  • Manage all activities associated the application of reagents and production of test strips for all Chembio diagnostic products. This includes employee training (hands-on demonstration and competency skills assessment), retention and performance development.
  • Responsible for working with Planning and Inventory Management to execute assigned work to meet customer requirements. Allocate resources accordingly to assure work is conducted in compliance with manufacturing batch records / quality system requirements, including manufacturing standards.
  • Establish and improve procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards.
  • Ensure all employees are trained and current with up-to-date quality management standards and practices
  • Ensure consistent execution according to batch records, and that all Production operations are performed according to established SOPs.
  • 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 Director of Manufacturing, Planning, and Quality regarding any nonconformances that arise during processing that will impact scheduled product or delivery dates. Lead the effort to eliminate nonconformances and deviations.
  • Provide daily updates of activities.
  • Coordinate with the Formulations Lab Team Leader to ensure the correct quantity and quality of material is received for application at specified time points.
  • Directly collaborate 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. Investigate and correct variances in labor and equipment efficiency standards.
  • Create, measure and communicate agreed to key performance indicators.
  • Participate in root-cause investigations related to product problems, lot failures and yield discrepancies and recommending corrective and preventative actions.
  • Assist R&D and Regulatory in product transfers, design control, risk management, and RIR investigations.
  • Develop and implement training programs to increase the knowledge and skills level of staff.
  • Collaborate with Technical Operations / Engineering and R&D to assure compliance with technical studies and validation protocols as required.
  • Identify and recommend opportunities to improve productivity and reduce cost in collaboration with Technical Operations / Engineering and R&D.
  • Investigate and correct variances in labor and equipment efficiency standards.

Qualifications Required:

  • Bachelors degree or higher in a science related field.
  • Minimum of five year’s experience in the manufacture of diagnostic testing devices.
  • Excellent verbal and written communications skills
  • Knowledge of GMP’s, ISO and FDA guidelines related to industry.
  • Knowledge and experience related to process validations.

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