Director Radiation Compliance and Environmental Health and Safety (EHS)

Title | Director Radiation Compliance and Environmental Health and Safety (EHS)
Location | Open to any SOFIE location
Department | Quality/Regulatory/EH&S
Reports To | Vice President, Quality

Overview
SOFIE is committed to all aspects of Quality, Compliance, and Safety in the production of the Radiopharmaceutical products they manufacture. This is a high-profile role providing Compliance and Safety leadership to the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The Director Radiation Compliance & EHS ensures that operations are conducted in accordance with the regulations of OSHA, BOP, NRC, and various other state and federal agencies. In addition, he/she performs radiation safety audits of facilities, responds to and investigates incidents and events, develops and administers training programs, corresponds with regulatory agencies, evaluates occupational risks and exposures, ensures applicable licenses and permits are maintained, and ensures proper hazardous material handling and disposal.

Essential Duties and Responsibilities
 Serve as the Corporate Radiation Safety Officer
 Surveillance over all radioactive material, including routine monitoring, special surveys, and responding to events
 Provide training and development of all employees regarding safety and regulatory compliance
 Train and enforce all DOT procedures and requirements
 Promote safety in and outside the workplace using a variety of materials to ensure continued awareness to safety practices
 Perform audits and provide timely responses (internal & external)
 Proper filing of health physics
 Develop and oversee a Radiation & Environmental, Health, and Safety Manual.
 Monitor performance of fume hoods that are associated with isotope work
 Serve as the primary source of radiation protection information for personnel at all levels of responsibility
 Compliance oversight to employees responsible for the preparation of all shipments of radioactive material leaving a nuclear facility (manufacturing or pharmacy)
 Compliance oversight of the receipt, opening and delivery of all shipments of radioactive material arriving at the nuclear facility
 Oversee the distribution and processing of personnel monitoring equipment
 Oversee and coordinate the radioactive waste disposal program
 Oversee the safe storage of all radioactive materials not in current use
 Ensure that sealed sources are leak-tested at proper intervals
 Maintain an inventory of all radioactive materials and limiting the quantity of radionuclides at the facility to the amounts authorized by the license
 Oversee applicable regulatory licensing and renewals
 Review license procedures and controls based upon sound radiation protection principles, to ensure that occupational doses and doses to members of the public are as low as reasonably achievable (ALARA)
 Use administrative controls to avoid mistakes in the administration of by product material
 Use procedures to prevent or minimize contamination and use proper decontamination procedures
 Maintain and oversee all radioactive tasks as related to pharmacy and manufacturing facilities
 Ensure company operations are conducted in accordance with the regulations of the US NRC, DOT and other federal and state agencies
 Respond to and investigate incidents and events
 Develop and administer training programs
 Correspond with regulatory agencies
 Evaluate internal and external dosimetry, and perform radioactive material licensing tasks
 On call availability is required
 Provide input and support to QA on various quality and regulatory initiatives
 The position will often require more than forty hours of work per week
 Individuals in this position will be exposed to radiation; however, radiation safety training and monitoring is required.
 All other duties as assigned.

Qualifications
 B.S. Physics, Health Physics, Radiation Biology, Radiochemistry or closely related field w 5+ years related experience
 CHP certification preferred
 Must have or be able to obtain proper licensing and certifications to perform essential functions of the job.
 Knowledge of OSHA, BOP, NRC, and various other state and federal agencies regulations.
 Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision and as part of a team required.
 Ability to analyze and interpret technical procedures and governmental regulations.
 Ability to write reports, business correspondence and procedure manuals.
 Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
 Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
 Ability to define problems, collect data, establish facts and draw valid conclusions.
 Proficient in Microsoft suite.
 Experience performing compliance and safety audits preferred.
 Ability to lift 50-60 pounds on a regular basis.
 Travel: 35%