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location: North Billerica, Massachusetts
job type: Permanent
salary: $35,000 - 40,000 per year
work hours: 9 to 5
education: High School
Perform GMP cleaning and disinfection services to controlled environments in preparation for manufacturing and research activities.
- Perform cleaning and disinfection services within controlled environment manufacturing areas (i.e. clean rooms) to ensure compliance with current Good Manufacturing Practices (cGMP) and US Food and Drug Administration (US FDA). Maintain the assigned area housekeeping (per cGMP compliance) such as: cleaning walls, floors, doors, drains, windows, and other general surface areas.
- Work must be performed following Occupational Safety and Health Administration (OSHA) and Massachusetts Radiation Control Program requirements.
- Follow written standard operating procedures to fulfill cGMP requirements for cleaning and disinfection of controlled clean room environments. Properly document completion of facility cleaning/disinfection in the form as required per SOP.
- Respond to emergency requests for cleaning services such as radiological decontamination and facility cleaning and disinfection on a time-critical basis, on and off normal work hours.
- Maintain cleaning equipment in good working condition, maintain cleaning/disinfection inventory, and keep cleaning supplies and equipment storage areas in neat and safe order.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety and environmental hazards.
- Actively demonstrates the values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.
- This position may require mandatory overtime, as needed, supporting finishing operations on holidays, weekends, and/or late and early production shifts.
- High School diploma, or equivalent.
- 1-3 year(s) experience in cleaning and disinfection services within controlled clean room environments.
- Ability to understand and execute against cGMP regulations and standard operating procedures (SOPs), and follow verbal and written instructions.
- Possess knowledge of cleaning and disinfection techniques and use of cleaning and disinfection equipment in a pharmaceutical environment.
- Demonstrate trouble-shooting and clear communication skills.
- The incumbent must be able to work in a clean room environment wearing special garments while performing duties.
- Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- Required to work within radiological restricted areas.
- Required to work with cleaning and disinfection agents (Spor-Klenz, Vesphene, Isopropyl alcohol, etc).
- Safety shoes, safety glasses, uniforms and personal air purifying respirator provided.
- Must be able to lift, push, pull and carry up to 50 lbs.
- A combination of education, training, and experience may be considered in lieu of the above stated qualifications.
skills: SOP, FDA, GMP (Good Manufacturing Practice), Sanitation, Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.