To carry out the day-to-day operation and supervision of over 50 production personnel involved in manufacturing of product for the facility. Maintains general control to ensure compliance with domestic FDA/GMP and all international regulatory requirements. Responsible for ensuring compliance is maintained in the area concerning environmental, health and safety practices. Directs and oversees Leads 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, prioritization and established quality standards. Provides daily/weekly reports on total production efficiency and quality variances. 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 on a daily basis.
Conduct and update on an ongoing basis the training of personnel, as well as testing of new processes and procedures, to ensure that both production personnel and processes conform to 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 direct reports 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.
Bachelor's Degree. Equivalent experience may be considered.
Demonstrated knowledge of basic computer skills. (Word, Excel & PowerPoint). Ability to learn new software as it applies. (Documentum, ERPLX, MS Project, Visio, etc.)
Demonstrates excellent verbal and written communication skills, leadership, interpersonal skills, eager to drive and implement change to improve business results and able to effectively manage and supervise employees in a Union environment.
ISO 13485 and GMP's, ISO 14001, OHSAS 18001.
5 years demonstrated experience supervising or directing
Employees in a semi-automated metals manufacturing environment with total employee responsibility of 10 - 50 employees.
Previous medical device or pharmaceutical manufacturing experience preferred. Knowledge of domestic and international regulatory requirements related to manufacturing, such as FDA GMP's and ISO standards preferred.
Metal working experience preferable.