Description
Principal Accountabilities:
• Ensure compliance with the regulatory requirements of the Arizona Radiation Regulatory Agency, the U.S. Nuclear Regulatory Commission, the FDA and the Arizona Administrative Code.
• Communicate Arizona Board of Pharmacy directives to management, other pharmacists, interns, and other personnel as required.
• Must be present in the facility whenever a radiopharmaceutical is manufactured, packaged, repackaged, labeled, relabeled or distributed.
• Ensure receiving, storage and handling, manufacturing, and distribution activities are in compliance with FDA Current Good Manufacturing Practices and Arizona Board of Pharmacy Administrative Code.
• Verify the establishment and implementation of all written procedures for maintaining records pertaining to production, process control, labeling, packaging, quality control, distribution, complaints, and any information required by federal or state law.
• Ensure records are maintained according to requirements as specified by Arizona Board of Pharmacy and 21 CFR, Part 210/211.
• Review and audit all drug and radiopharmaceutical manufacturing records.
• Ensure radioactive waste is logged, stored and destroyed in accordance with Arizona Administrative Code and Nuclear Regulatory Commission requirments.
• Coordinate with Quality Assurance Team to make records available within 48 hours for review by a Board compliance officer or other authorized officer of the law.
• Co-host facility inspections by the Arizona Board of Pharmacy compliance officer or other regulatory authority.
• Communicate fully with superiors, subordinates and others who have need to know.
• Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
• Establish and maintain internal control within his/her area on responsibility in accordance with all applicable Standard Operating Procedures, Good Manufacturing Practices, and Corporate Financial Instructions.
• Maintain direct compliance with Arizona Board of Pharmacy, FDA, NRC, DRC and ISO regulations within area of responsibility.
• Provide expert testimony if required at court and administrative hearings.
• Respond to customer needs in an accurate and timely fashion.
• Perform related work as assigned.
Requirements
Required Skills
Must be certified by The Board of Pharmaceutical Specialties as a nuclear pharmacist holding a current Arizona Radiation Regulatory Agency Radioactive Materials License. Typically 3-5 years experience is required involving the manufacturing, compounding, dispensing, storing, and disposal of drugs and radiopharmaceuticals. Written evidence of certification must be provided as well as evidence of a solid background of specialized knowledge and leadership experience is desired.
Additional critical skills required for the position:
• Oral communication
• Decision making
• Good moral character
• Motivating
• Collaboration
• Influence
• Cognitive power
• Business intuition
• Results orientation
• Trustworthiness
