Manufacturing Associate - Radiomedix, Inc.

• Aseptic manufacturing experience preferred, does not require radioactive compounding experience. The individual will be trained on the job.
• Prepares radioactive compounded preparations in accordance with standards of practice.
• Perform the duties associated with compounding, dispensing, and distribution of radioactive products GaPSMA, Re186-nanoliposome, Ac225 PSMA, including data entry with paper-based production records.
• Ensure compliance with USP <797>, <823>, proposed <825> regulations.
• Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations.
• Perform aseptic techniques within a cleanroom environment for the preparation/processing of materials (ISO 5/7/8 clean room environments).
• Maintain a clean and safe working environment.
• Perform radiation safety duties according to company’s Corporate Radiation Compliance Program and site licensing requirements.
• Clean classified and non-classified areas according to SOPs.
• Perform environmental monitoring of classified areas according to SOPs.
• Complete cGMP documents as required and assist site and Quality Assurance as required.
• Routinely originate or revise standard operating procedures (SOPs) and batch production records (BPRs). Performs manufacturing operations according to SOPs and BPRs.
• Perform process validation activities.
• Responsible for manufacturing radiotheranostic APIs and drug products.
• Utilize quality management system software (PETRA) to complete manufacturing and inventory management documentation.
• Assist RSO in Radiation Safety including wipes and surveys.

• Excellent organizational skills and attention to detail
• Strong analytical and problem-solving skills
• Ability to work independently towards self-directed goals
• Proficient with Microsoft Office Suite or related software
• Strong proficiency with Microsoft Excel preferred

• 2-3 years of aseptic manufacturing or compounding pharmacy technician experience preferred.
• Sterile compounding experience preferred.
• High School Diploma or equivalent is required.
• Efficient in the use of MS Office Suite required.

• Standard office environment, coupled with approximately 70% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
• Willingness to work in commercial manufacturing producing radioactive materials and safety programs designed to minimize potential and/or actual exposure levels.
• Must be willing to wear a variety of personal protective equipment.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours, including weekends and overtime as needed.

• Employees must permanently reside and work in the State of Texas.

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