Summary of Position

Performs all tasks associated with assembling, formulating, dispensing, and packaging of radioactive components Reactor Hot Products (RHP) Lab according to cGMP guidelines in order to meet production demands.

Participate in the manufacturing process within a team environment and interact with multiple departments to ensure the operational success of the facility.

Train on aspects of the manufacturing process in the area(s) including but not limited to : overall process, individual task, trouble shooting, escalation plan, safety concerns, documentation, cleaning, cGMPs, SOPs, company policies, gowning and lean processes such as 5S and Kiazen.

Work Schedule : Saturday Tuesday 5 : 30pm 4 : 00am. Ability to work overtime as needed.

Essential Functions

Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.

Ensure the maintenance of their department, premises and equipment.

• Conduct room release to check for exceptions that would hinder effective production.
• Ensure proper maintenance and cleanliness of department (structure of area), premises (facilities) and equipment (all equipment and tools), report any deficiencies to coordinator and / or supervisor.
• Walk-through to check for irregularities that would hinder effective production.
• Perform line clearance to ensure nothing left from the previous lot and that the room is clean.
• Keep extensive log books to record important information in order to ensure compliance.
• Set up, maintain, operate and clean equipment and work area according SOPs and cGMP guidelines. Immediate report any item not working or in proper cGMP condition.
• Pick up and deliver raw materials from loading dock to production area using pallet jacks.
• Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines.
• Accurately label selected products with tracking and the appropriate FDA labels.
• Accurately count materials and labels to track used and unused raw materials for placement in the batch record.
• Demonstrate the ability to participate in the production processes with supervisor and / or leadership support. Monitor product quality to ensure compliance with standards and specifications.
• Awareness of FDA, NRC, ALARA, and OSHA requirements.
• Assist and support (when appropriate), investigation, reliability team meeting, root cause analysis, SOP and Batch record improvements, Kaizen, Customer Complaints, data collection and downtime issue resolutions.
• Provide and maintain a safe work environment by participating in safety programs, committees, or teams and by conducting laboratory or plant safety audits.
• Prepare some chemical solutions for products or processes, following standardized formulas, or create experimental formulas.
• Maintain, clean, or sterilize laboratory instruments or equipment.
• Provide technical support or assistance to chemists or engineers.
• Order and inventory materials to maintain supplies.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Develop and train personnel to ensure a cross functional operations culture.
• Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
• Required to perform other duties that are not routinely part of direct responsibilities based on direction of manager’s / supervisor’s discretion to support overall business needs.
• Wiliness to be flexible and adaptable to the needs of the department and business.
• Inspect finished products for quality and adherence to customer specifications.
• Set up and verify the functionality of safety equipment.
• Monitor and adjust production processes or equipment for quality and productivity.
• Troubleshoot problems with equipment, devices, or products.
• Test products or subassemblies for functionality or quality.
• Start up and shut down processing equipment.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).

Requirements

• High school diploma or GED equivalent is required. Associate degree is preferred.
• One or more years of relevant work experience in manufacturing required (regulated environment, attention to detail, and following detailed instructions).
• Knowledge of Good Manufacturing Practices c(GMP) and applicable Quality System Standards.
• Must be willing to work around radioactive and / or non-radioactive materials.
• Willingness to work rotating shifts, weekends, and overtime, as necessary.

Working Conditions :

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and / or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical / moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

Last updated : 2024-04-23