Supports production of Eye90 unit dose preparation as coordinated by the Nuclear Operations Manager.
Supports development activities related to Eye90 as coordinated by the Nuclear Operations Manager.
Employs high standards of workmanship to ensure high-quality products are produced on schedule.
Generates and completes required documentation for the Device History Record (DHR) on time with adherence to good documentation practices (GDPs).
Offers suggestions on improvement of processes and methods.
Supports equipment maintenance and calibrations program.
Coordinates QC final release testing with MURR (Missouri University Research Reactor) QC.
Coordinates receipt and transfer of irradiated product from MURR to ABK Hot cell.
Assists in creating and updating process and product documentation.
Keeps work areas clean, organized and safe.
Responsible for performing all duties safely and in compliance with the US Food and Drug Administration's Quality System regulations (FDA's QSR), ISO 13485 and all other regulatory requirements with which ABK Biomedical complies.
Adherence to ABK Biomedical procedures, including quality and safety.
Maintains currency of training on relevant ABK work instructions and standard operating procedures.
Supports inventory management, maintenance programs, and logistics coordination for the outbound final product.
Communicate observations and data in meetings and reports.
Provides guidance to Nuclear Operations Assistant(s) to achieve ABK objectives.
Experience Required:
Basic Qualifications include:
Post-secondary education, preferably in a technical/science discipline.
Candidate must be self-motivated and able to multi-task and work without direct supervision.
Candidate must be able to work with a cross-functional team in a fast-paced environment.
Excellent analytical and communication skills, both verbal and written, as well as training skills.
Good mechanical aptitude, dexterity, and hand/eye coordination. Must be able to reach, bend, and lift daily.
Candidate must be proficient in using various types of computer software.
Able to meet MURR requirements as a radiation worker/nuclear operator.