Manufacturing GMP Cleaner
POSITION OBJECTIVE: As our Manufacturing GMP Cleaner, you will be performing cleaning of a pharmaceutical manufacturing area utilizing industry standard cleaning agents and sanitization agents (such as, sporicidal, surfactant, or hydrogen peroxide).
This is a second shift position. Hours are 2 PM to 10:30 PM, Monday through Friday. Start and end times may shift due to needs of production support.
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 may be 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.
· Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown. Position requires the ability to wear high level aseptic gowning for long periods of time.
· 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
· This position requires the passing of a pre-employment drug screen in compliance with federal drug testing rules.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.
This is a safety sensitive position and/or a position which has the potential to significantly impact the health or safety of other employees or members of the public. It requires passing a pre-employment drug screen in compliance with federal drug testing rules.