Radiopharmaceutical Production Support TechnicianPerspective TherapeuticsCoralville, IA
Objective The Radiopharmaceutical Production Support Technician provides production support to the manufacturing team in a just-in-time environment to support clinical and commercial demand. They are responsible for overseeing and executing all tasks associated with receiving and opening packages, updating and maintaining inventory, along with COAs, SBMs, media fill, and other production preparation, assembling, and packaging of components, adhering to cGMP Guidelines to meet production demands. S/he serves as a key resource while coordinating work within the standard operating procedures (SOPs). Essential Functions Responsible for ordering, inspecting, and inventorying raw materials, equipment, solutions, compounds, instruments, PPE, etc. Ensures items are properly labeled, stored, and tracked per SOPs and regulatory requirements. Maintains accurate and detailed inventory; alerts management when supplies are running low. Collaborate with the Purchasing Coordinator in managing purchase orders, reconciling packing slips, and maintaining accurate inventory records in ERP or inventory management systems. Supports all technical aspects related to pharmaceutical production readiness including manually cleaning the classified manufacturing rooms, performing environmental monitoring and performing sterilization of the isolators. Coordinates with QA to ensure materials are released for use, and tracks Certificates of Analysis (COAs) and other quality documentation. Demonstrates advanced proficiency in following quality, safety, regulatory guidance, and written procedures. Performs batch record calculations and maintains all documentation according to cGMP guidelines. Assists in performing deviation investigations and inspections. Participates in assigned qualification and validation activities, as necessary. Plays a key role in cross-functional teamwork, collaborating with multiple departments to ensure the operational success of the area. Exhibits flexibility in accommodating the changing needs of the department and business. May need to work extended hours, and or weekends, on occasion per business needs. Education / Experience Associate degree or equivalent experience. College-level coursework with a strong scientific background is highly desired. Minimum of 2 years of relevant work experience in inventory control, materials management and logistics in the pharmaceutical or a cGMP manufacturing industry. Experience using inventory or ERP systems (e.g., SAP, Oracle, NetSuite) preferred. Highly organized with working knowledge and experience with MS Office Suite. Aseptic processing and technique experience is preferred. Knowledge / Skill / Ability Proficient in handling and managing radioactive materials, with a comprehensive understanding of safety protocols to minimize exposure levels. Actively participates in and contributes to advanced safety programs aimed at ensuring the utmost protection for all personnel. Capable of handling physically demanding tasks, including lifting loads up to 50 lbs. and performing frequent crawling, stooping, crouching, and kneeling. Maintains a high level of fitness and agility to excel in challenging work environments. Extensive experience and willingness to use a variety of advanced personal protective equipment, ensuring strict adherence to safety guidelines and regulations. Proven ability to thrive in a team-based environment, taking on leadership roles when necessary. Collaborates effectively with colleagues, and other departments, vendors, suppliers, etc., demonstrating advanced interpersonal and communication skills to foster a cohesive work environment. Flexibility to work varying shifts, including overnight and weekends, exhibiting a commitment to meeting production demands and deadlines. Highly organized with an exceptional attention to detail. Possesses the ability to manage complex tasks and projects, ensuring a commitment to delivering high-quality work consistently. Demonstrates ownership and accountability for the inventory integrity, documentation accuracy, and material readiness for production operations. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Hazards include radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 30 lbs. and to frequently handle, grab, use fingers, hold, pipet, etc. Must possess good hand-eye coordination; close attention to detail is required. Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required. Must be willing to wear a variety of personal protective equipment. Willingness to complete safety training within allotted timeframes, adhere to safety guidelines, and work in a team-based environment. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notic e. Powered by JazzHR
Posted 6 days ago