This position reports directly to the Production Supervisor or Manager, as assigned. The role supports manufacturing activities by cleaning, disinfecting, and sanitizing aseptic cleanroom environments between production shifts and completing corresponding documentation within an outsourcing facility.
- Responsible for disinfecting aseptic areas per Leiters’ SOPs:
- Complete routine and enhanced cleaning of aseptic cleanrooms and supporting areas using defined techniques.
- Aseptically don sterile garbing and demonstrate aseptic technique while in the cleanroom environment.
- Accurately prepare, label, and use cleaning materials and solutions.
- Accurately sort and dispose of pharmaceutical waste materials.
- Follow SOPs, product batch record instructions, and corresponding quality documentation in detail.
- Prepare and maintain accurate documentation following cGMP principles.
- Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns and areas for improvement in quality, yield and efficiency.
- Recognize inappropriate directions and/or equipment operation and notify management accordingly.
- Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
- Adhere to all facility safety policies and procedures and proactively identify unsafe conditions.
- Be able to lift up to 40 lbs. and stand for extended periods of time when required.
- Perform additional equipment setup or preparation activities in support of production as assigned.
- Maintain all sanitation related equipment.
- Other duties as assigned.
EXPERIENCE AND NECESSARY SKILLS:
- High school diploma or GED required
- Understanding of aseptic techniques/environments and cGMP requirements preferred
- Experience in a manufacturing environment or healthcare industry preferred
- Knowledge of materials and techniques used in sterile manufacturing, cleaning and gowning preferred
- Knowledge of and familiarity with controlled environment equipment and area(s)
- High integrity and the ability to work in changing environment
- Good interpersonal and communication skills, both verbal and written
- Willing to work extended hours, complete repetitive tasks and stand for prolonged periods of time
- Ability to work on your own or within a team environment, with good organizational skills. Detail oriented.
- Certification of recent (less than one year) eye exam with minimum 20/30 vision