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,