Pharmacy Technician (Sterile Compounding) Job at Radiomedix, Inc., Humble, TX

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  • Radiomedix, Inc.
  • Humble, TX

Job Description

About us:
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Pharmacy Technician to work at its newly constructed GMP radiopharmaceutical manufacturing facility.

Manufacturing Associate Responsibilities:
  • 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.
Required Skills/Abilities:
  • 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
Qualifications:
  • 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.
Physical Requirements:
  • 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.
Residency Requirement:
  • Employees must permanently reside and work in the State of Texas.

 

Job Tags

Full time,

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