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Manufacturing Specialist

2 months ago

Frederick, United States Integrated Resources, Inc ( IRI ) Full time

We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup of Client’s brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland. The cGMP Cleaner, internally known as a Lab Tech I, 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)

• Perform operations within an ISO Class clean rooms

• Employee must be able to occasionally lift and/or move up to 40 pounds

• Employee must be able to wear a respirator during use of certain cleaning chemicals

• 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