To carry out the day to day operation and supervision of production personnel involved in manufacturing of product for the facility. Maintains general control to ensure compliance with all regulatory requirements. Responsible for ensuring compliance is maintained in the area concerning environmental, health and safety practices. Directs and oversees Leads, Trainers and employees to accomplish established objectives.
Directs the daily production schedule for manufactured products to ensure that the products are produced according to the prescribed schedule and established quality standards.
Analyzes the daily production schedule to ensure that personnel staffing and process capabilities will allow scheduled production to be attained.
Provides daily reports on total production efficiency and quality variances to ensure that production processes conform to prescribed production schedules.
Directs the collection of performance data for each process and for the personnel in each area, to determine the productivity and efficiency of the operation to a daily basis.
Conducts and updates on an ongoing basis the training of personnel, as well as testing of new processes and procedures, to ensure that both production personnel and process confirm with GMP’s and all regulatory and safety requirements.
Identifies in process control problems and corrects or enlists technical support to ensure deficiencies are corrected.
Conducts regular meetings with employees of manufacturing to communicate objectives, goals and results.
Participates and involves employees in company-wide Quality improvement process and project teams. Complies with all environmental, health and safety related activities.
Education: Bachelor Degree Preferred
Experience: 1-3 years demonstrated experience supervising or directing employees in a semi-automated manufacturing environment with total employee responsibility of a minimum of 10 employees. Previous medical device or pharmaceutical manufacturing experience preferred. Knowledge of domestic and international regulatory requirements related to manufacturing.
Special Skills: Demonstrated knowledge of computer/software (Microsoft Word, Excel & PowerPoint). Able to learn and use Shop Floor Control Software (CAMS).
Specialized Training: ISO 13485 and GMP’s, ISO 14001, OHSAS 18001.
Manufacturing experience in a medical device or pharmaceutical environment providing supervision, direction, training and technical guidance to direct labor employees.