Overview

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Work Schedule: Wednesday - Saturday: 4:00pm - 2:30am

Responsibilities

• Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE)
• Perform cleaning methods, such as wiping techniques of equipment, wall and ceiling and floor mopping techniques.
• Responsible for the operation, maintenance and cleaning of equipment
• Responsible for the cleaning/sanitization solution and material preparation
• Possesses basic technical knowledge and background
• Understands aseptic technique concepts/proper cleanroom behavior
• Responsible for receiving and the organizing of gowning and cleaning materials
  Identifies and communicates material discrepancies
• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs)
• Follows and executes Standard Operating Procedures (SOPs)
• May participate in the training activities of others on SOPs, equipment, all unit operations and non-manufacturing SOPs
• May participate in the training activities of others on basic operations such as cleaning/sanitization of cleanrooms, cleaning and maintenance of equipment, solution and material preparation
• Participates with technical documents such as non-conforming events and deviations
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests continuous improvement ideas
• Follow Proper cleaning/disinfecting schedules
• Assist Supervision with internal pre-audits walkthroughs, CGMP housekeeping and general organization and upkeep of manufacturing spaces

Qualifications

• High School diploma or equivalent
• 1-2 years of relevant or equivalent experience

Advanced Therapies, LLC provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.