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


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