Quality Assurance Leader

Quality Assurance Leader

Full-time Regular

Hawai’i Isotope Technology (HIT), Hawai’i

Join a pioneering company dedicated to revolutionizing cancer detection and treatment in Hawaii. Our brand-new facility is equipped with cutting-edge technology, allowing us to make a meaningful impact in cancer diagnosis and patient care. As a small, dynamic team, we foster a collaborative, family-like environment where innovation thrives. Here, you’ll have the unique opportunity to influence strategy and help introduce groundbreaking new treatments to the state. If you’re passionate about advancing cancer care and want to be part of a team shaping the future of healthcare, we’d love to have you on board!

Role Summary:

Quality Assurance (QA) Leader will have regulatory oversight for the synthesis and quality control (QC) testing of PET and SPECT radiopharmaceuticals according to cGMP regulations (e.g. 21 CFR 212). This will entail building, implementation and maintenance of a quality management system, oversight for inventory management and LIMS systems, management and maintenance of regulatory filings, as well as coordination of investigations and CAPA. Role may also involve assistance with routine operation, troubleshooting and maintenance of HIT equipment, including a newly installed GE PETtrace cyclotron, GE FASTLab synthesis modules, state-of-the-art analytical equipment and other infrastructure such as a clean room and hot-cells. The role also includes isotope production (including 18 F, 68 Ga) using both liquid and solid targets, routine production of radiopharmaceuticals (manufacturing, quality control and distribution of PET and SPECT radiopharmaceuticals to satellite sites throughout the state of Hawai’i) as needed, and liaising with facility leadership and pharmacy staff to ready radiopharmaceutical doses for shipment. In addition to this primary responsibility, the position will liaise with vendors for routine maintenance and other contract services, and support site leadership in meeting company goals, building a safety culture, and regulatory compliance.

Job Responsibilities and Duties:

• Responsible for overall facility regulatory compliance, including building and implementing a Quality Management System;

• Design and routine operation of facility inventory management / LIMS systems;

• Oversight for regulatory documents required for clinical PET tracer filings such as INDs and (A)NDAs.

• Coordinate and manage regulatory inspections and correspondence with regulatory agencies, including data generation and document writing, interfacing with facility leadership as needed;

• Overall responsibility for quality and regulatory compliance initiatives and routine monitoring / tracking / trending, coordinating with facility leadership as appropriate;

• Advise facility leadership on operating a cyclotron facility that meets all applicable regulatory requirements, including Nuclear Regulatory, State of Hawaii, Food and Drug Administration, and other applicable federal, state, and local island regulations. This includes working with leadership to assure all equipment is maintained in a validated compliant state (e.g. completion of IQ/OQ/PQ, annual preventive maintenance etc);

• Oversight for quality investigations (NCR/OOS) and corrective and preventative actions (CAPA); • Oversight for SOP (Standard Operating Procedure) writing, maintenance and review as they pertain to equipment and maintenance;

• Ensure inspection readiness;

• Perform synthesis and quality control of PET and SPECT tracers according to cGMP regulations (USP823 and 21 CFR212) as needed. Conduct routine production, QC testing (including pre-release QC and post-release sterility testing), packaging and shipping of radioisotopes;

• Assist with day-to-day operation of the GE PETtrace cyclotron, FASTLab radiochemistry modules and analytical equipment, including equipment maintenance/ qualification/ calibration/ system suitability;

• Accurate record keeping for lab books, equipment logbooks and production batch records is a must;

• Present synthesis and QC results, as well as investigations, CAPA etc at internal meetings;

• Order parts and supplies for maintenance pf production/QC equipment. Materials acceptance and quarantine for the inventory system;

• Assist facility engineer with facility maintenance and upkeep to ensure the GE PETtrace cyclotron, GE FASTLab synthesis modules, Comecer hot-cells, clean room/laminar flow hoods and QC analytical equipment is in good operating order and available for radiopharmaceutical production according to the HIT pharmacy schedule;

• Clean and maintain the facility to maintain air quality and other standards and compliance according to established procedures;

• Work with facility RSO and leadership to maintain a culture of safety in the facility, including safe operation of the accelerator and synthesis modules;

• Assist facility engineers and leadership with routine maintenance, calibration, and repair tasks for the cyclotron, GE FASTLab 2 radiochemistry synthesis modules, associated systems such as HPLC+, and software;

• Assist facility engineers and leadership with routine maintenance on other facility equipment (hot-cells, analytical instruments, support infrastructure, clean room, other equipment) as needed;

• Assist facility engineers and leadership in promptly troubleshooting cyclotron, module and/or other equipment problems as they arise;

• Maintain accurate complete records of all the machine’s operation, calibration, and maintenance, electronically and/or in physical log books;

• Assist with inventing, modifying, or improve cyclotron/synthesis module components and targetry, through collaboration with GE as needed, to support the growing mission of HIT;

• Assist RSO with radiation safety program, including assisting with radiation wipes and surveys on shipping containers, supplies, incoming packages, and workspaces;

• Assist facility leadership in acquisition, installation and operationalizing new capital equipment as needed for future facility modifications, including accelerator equipment, clean room modifications, hot-cells, automated synthesis or packaging equipment, and analytical equipment.

• Perform other job-related duties as assigned.

Job Requirements │ Skills │ Education :

• Academic background in chemistry, engineering, physics or electronic technology; or completion of training at an advanced military electronics school; or an equivalent combination of education and experience preferred.

• Pharmacy License preferred

• Additional experience working in an industrial or academic PET and/or SPECT facility is highly desirable;

• Experience with a GE PETtrace (or related) cyclotron and radiochemistry synthesis modules is high desirable;

• Familiarity with a GMP manufacturing environment and working with board of pharmacy, NRC and FDA cGMP regulations is highly desirable;

• Knowledge of radiopharmaceutical production and distribution desired;

• Experience working in a multidisciplinary radiopharmacy team environment is strongly preferred;

• Experience with cyclotrons, radionuclide generators, radiochemistry synthesis, US FDA cGMP, QC testing (e.g. HPLC, GC, TLC, sterility testing), radiation safety principles, isotope production and analytical equipment troubleshooting and maintenance a plus;

• Superior teamwork, multi-tasking, and time/project management skills are essential;

• Excellent communication, analytical, problem solving, and computer/pc skills (including proficiency in Microsoft Suit and related software);

• Ability to work varying shifts;

• Ability to build and maintain excellent working relationships with providers of routine maintenance, couriers and other contract services and material suppliers is expected.

Salary:

$125,000-$155,000

Physical and Intellectual Requirements:

Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling; ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

Come join our team and begin a fulfilling career with us by applying today.

Hawai’i Isotope Technology is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

Benefits Include:

401(k) retirement benefit program

Medical

Dental care

Disability insurance

Life insurance

Paid time off

Vision care