Job Title cGMP Cleaner
Hours: 5x8 hours days 10:30pm- 7:00am (mandatory 1 weekend day a week)
Training hours: 1st three weeks Monday- Friday 7:30am-4:00pm
Location: 100% Onsite Frederick, MD
" Description
GMP cleaning team Job Title cGMP Cleaner Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta and Tecartus , along with a robust pipeline of various autologous and allogeneic clinical programs. We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Kite s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech II, 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
" Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
" Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
" Maintains accurate and complete records
" Attends and completes all training required by Company SOPs, procedures and policies
" Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
" Reviews and provides signatory signoff of documentation
" Provides accurate and complete assistance to other Departments as needed
" Works 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
Basic 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)
"Ability to wear a respirator during use of certain cleaning chemicals
"Perform operations within an ISO Class clean rooms
" Employee must be able to occasionally lift and/or move up to 40 pounds
" 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 Task break down (by %): 75% cleaning 15% documentation 10% other duties as assigned
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.