Manufacturing Specialist

18 hours ago


Frederick, Maryland, United States Integrated Resources, Inc ( IRI ) Full time
Job Title: cGMP Cleaner

We are seeking a highly motivated individual to support the startup of our state-of-the-art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner will provide 3rd shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.

Responsibilities:
  • Perform sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
  • Perform sterile and non-sterile stocking, staging, and shifting (FIFO) of usable garments for multiple gowning rooms
  • Maintain accurate and complete records
  • Attend and complete all training required by Company SOPs, procedures, and policies
  • Maintain accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
  • Review and provide signatory signoff of documentation
  • Provide accurate and complete assistance to other Departments as needed
  • Work in a safe and effective manner in accordance with all company, state, and federal rules and regulations
  • Perform any other tasks/duties as assigned by management
  • Embrace the QUALITY culture
Requirements:
  • AA Degree
  • OR
  • High School Degree with 1+ years of operations and/or pharmaceutical/biotechnology and/or manufacturing experience
Physical Environment and Physical Requirements:
  • Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
  • Perform operations within an ISO Class clean rooms
  • Employee must be able to occasionally lift and/or move up to 40 pounds
  • Employee must be able to wear a respirator during use of certain cleaning chemicals
  • Must be able to squat, bend, kneel, and/or reach for 80% of a shift
  • Must be able to stand, walk, and/or move about for 80% of a shift
Preferred Qualifications:
  • Clean Room sanitization experience or cGMP operational experience a plus


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