What are the responsibilities and job description for the Manufacturing Associate position at Radiomedix, Inc.?
About us:
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Manufacturing Associate 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 , , proposed 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:
760AyoTrlH
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Manufacturing Associate to work at its newly constructed GMP radiopharmaceutical manufacturing facility.
Manufacturing Associate Responsibilities:
- 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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