CGMP Cleaner

NET2SOURCE CONSULTING LIMITED; Frederick (MD); On-site; USD 33,000 - 48,000; Full time

Job summary

NET2SOURCE CONSULTING LIMITED is seeking a cGMP Cleaner (Lab Tech II) for a 12-month contract in Frederick, MD. The role involves 3rd shift cleaning in ISO Class rooms, sterile/non-sterile gowning stock, and strict adherence to GMP procedures.

The position requires 1+ year of pharmaceutical/manufacturing experience or an AA degree, with ability to wear PPE and operate in ISO clean rooms. Training occurs over the first three weeks, with weekend shift once per week.

Qualifications

• AA Degree OR High School Degree with 1+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience.
• Experience with cleanroom environments and PPE is preferred.
• Familiarity with cGMP and regulatory requirements is a plus.

Responsibilities

• Performs sanitary cleaning as defined by SOPs and directed by supervisor.
• Stocking and staging sterile and non-sterile garments (FIFO) for gowning rooms.
• Maintains accurate records and completes training per SOPs.
• Maintains inventory of cleaning supplies to prevent depletion.
• Supports other departments and adheres to safety regulations.
• Embrace the QUALITY culture.

Skills

Sanitation cleaning

Gowning PPE

Documentation

Inventory management

ISO class room compliance

Education

AA Degree or HS with 1+ years pharma/manufacturing experience

Job description

Location- Frederick, Maryland, USA, 21704

Duration- 12 months contract

Pay rate: $29.35/hr.

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

Description

We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and support the startup 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