Over 10 years of health and safety management experience, including development and implementation and maintenance of multiple programs across multiple sites in a highly complex, high risk environment. These environments include Pharmaceutical Analysis/Manufacturing, Emergency Medicine, Manufacturing (Fabrication/Machining/Assembly) of Large Products
Primary responsibilities included development and maintenance of Health and Safety Programs for a complex multi-site group that included fabrication, machining, assembly, and painting of large prime product (tractors). Program management included but was not limited to LOTO, Respiratory protection, hearing conservation, robot safety (trap key), incident investigation, Near Miss reporting, worker's compensation case management, SFMEA (risk assessment), ergonomics, Safety Champion (Cultural Program), ZIP (Zero Incident Process) and START (Supervisor Training and Accountability Recognition Techniques).
(Full-time after May 2011) Major responsibilities include patient care, ambulance operation, radio communication, and patient care documentation. Patient care includes Advance Live support techniques. Provide annual HAZMAT and Safety training as necessary.
Major management responsibilities include oversight of daily lab activities including execution of analytical methods and/or analytical methods transfer/validations, perform established methods independently, develop a series of tests to provide quality control for pharmaceutical raw materials, drug substances, or dosage forms. Solve complex problems with methods, instruments, or processes. Interpret data, draw conclusions, and make recommendations based on the data. Design method validation protocols and conduct validation experiments independently for pharmaceutical raw materials and dosage forms. Author analytical procedures, SOP's, validation documents, and other portions of regulatory submissions as directed. Responsible for group purchasing and scheduling. Directly supervise multiple staff members. Develop and implement policies, procedures, and programs.
Major safety responsibilities include monitoring and ensuring OSHA, EPA, and FDA regulatory compliance of laboratory facilities and staffing. Toxicological and overall safety review of all new entities entering facility. Incident mitigation, incident investigation, incident documentation, and Potent products specialist (handling and training). Evaluating new manufacturing equipment, manufacturing process lines and their application and annual review and continual improvement of current EHS policies and procedures. Hazardous Material management and disposal.
Major safety responsibilities include acting chemical hygiene officer, Lead Medical Responder, and Lead Hazmat Responder. Be knowledgeable of programs involved with safety, health, environment, and security Supervise HazMat Team and Safety Specialist Advise management on the safety and health of employees and the environment by interpreting the various safety, security, and environmental programs.
Responsibilities included the development, coordination, and implementation of a complex training program for the Pharmaceutical Analysis department. Responsibilities also include monitoring regulatory compliance of Pharmaceutical Analysis with respect to training and documentation of training (annual cGMP training, maintenance of training files, safety training, and regulatory updates). Other responsibilities included working with the management staff to identify and meet all training needs for the department, instrument coordination for multiple instruments and routine analysis as necessary.
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