What are the responsibilities and job description for the GMP Cleaning Technician position at Transpire BIO Inc.?
Job Specific Information:
The GMP Cleaning Technician is responsible for maintaining the cleanliness and sanitary conditions of controlled manufacturing environments in strict adherence to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and FDA regulations. This role is essential to prevent contamination and ensure product quality and safety.
Essential Duties and Responsibilities:
- Aseptic Cleaning: Execute specialized cleaning and disinfection procedures for critical areas, including ceilings, walls and floors within controlled/classified rooms.
- Solution Preparation: Accurately prepare and mix cleaning, sanitizing, and sporicidal solutions according to established SOPs, ensuring proper concentration and rotation.
- Compliance & Documentation: Maintain a high level of regulatory adherence to cGMP and site-specific protocols. Complete all cleaning logs and documentation records accurately and in real-time.
- Waste Management: Safely and effectively perform waste removal from the GMP production areas during the shift.
- Supply Management: Monitor and replenish all necessary consumables (e.g., wipes, garments, sanitizers) within the controlled environment to ensure operational readiness.
Education and Experience:
- Language Proficiency: Must be able to read, write, and verbally communicate fluently in English to understand SOPs and complete documentation.
- Compliance Knowledge: Proven ability to strictly adhere to Standard Operating Procedures (SOPs) and safety protocols.
- Physical Stamina: Ability to stand, walk, bend, and lift up to 60lbs and perform cleaning tasks requiring repetitive motion for extended periods.
- Schedule Flexibility: Must be able to work overtime, weekends, and accommodate planned schedule changes to support cleaning requirements.
- Prior experience in a GMP, controlled, or regulated environment is strongly preferred.