POSITION OBJECTIVE: Performing cleaning of pharmaceutical manufacturing area utilizing industry standard cleaning agents and sanitization agents (such as, sporicidal, surfactant, or hydrogen peroxide).
Essential Job Functions/Responsibilities
· Must work independently with minimal supervision and able to work in full clean room attire (i.e., full hooded clean room gown).
· Must be able to perform tasks with hands/arms raised above head for short periods of time
· Responsible for ordering, scheduling, receiving and the organization of gowning and cleaning materials
· Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by Athenex Pharma Solutions (APS); reports any injury or illness immediately and notifies APS of any hazards, unsafe acts or conditions in the workplace.
· Performs routine processes following written instructions (SOP) in support of the production of pharmaceutical products with adherence to FDA or cGMP guidance.
· Work in an aseptic production environment. Must be able to wear appropriate clean room attire (i.e. surgical masks, sterile gown) and all Personal Protective Equipment (PPE)
· Responsible for accurate completion of all cleaning documentation.
· Operate and maintain equipment and work area to ensure cleanliness and safety following GMPs and SOPs.
· Ensure that materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs.
· Contribute to achieving continuous improvement.
· Must work independently with minimal supervision.
· Must be able to work on your feet for 8-hour shifts
· Repetitive hip and upper body twisting movements.
· Ability to operate various forms of material handling equipment is required.
· Able to lift 25 pounds on a continuous basis
· Other duties as assigned.
Required Education & Qualifications
· Minimum high school diploma or equivalent
· Minimum of three years of experience in a production or pharmaceutical environment.
· Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
· Demonstrated effective written and verbal communication skills are required
· Able to utilize a computer for data entry is required. Knowledge in Windows, Word, and Excel desired.
· Understands aseptic technique concepts/proper clean room behavior
· Knowledge and understanding of basic math skills to perform calculations and conversions involving weights, volumes, and percentages
· Ability to work independently, within prescribed guidelines, or as a team member
· Demonstrated ability to follow detailed directions in a manufacturing cGMP environment as well as clearly and accurately documenting all necessary cleaning information
· Thorough understanding of regulatory requirements for cGMP manufacturing facility, especially as they apply to cleaning practices/sterile assurance
· Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents), and strong odors
· Need to be able to read, write and understand English