cGMP Cleaner

Spectraforce Technologies; Waldorf (MD); On-site; USD 25,000 - 36,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a cGMP Cleaner for our 3rd shift at the new Frederick, MD facility. Responsibilities include sterile/non-sterile garment stocking, 3rd shift cleaning, and compliant recordkeeping in ISO-class environments.

Qualified candidates have 1+ year pharma/manufacturing exposure and can work in PPE, with ability to lift up to 40 pounds and wear a respirator as needed. Training is provided; 1-year duration onsite.

Qualifications

• AA Degree or HS with 1+ year pharma/manufacturing experience.
• Able to wear PPE and respirator.
• Comfortable working 3rd shift and weekends.

Responsibilities

• Performs sanitary cleaning per SOPs and supervisor directions.
• Stocking and staging sterile and non-sterile garments for gowning rooms (FIFO).
• Maintains accurate records and completes training per SOPs.
• Maintains inventory of cleaning supplies and ensures supply levels.
• Reviews and signs off documentation as required.
• Supports other departments with needed assistance.

Skills

cGMP experience

Cleanroom gowning

Documentation

Education

AA Degree or HS + 1+ year pharma/manufacturing

Job description

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

Duration: 1 year

Description

Client 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 our 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
• Clean Room sanitization experience or cGMP operational experience a plus Task break down (by %): 75% cleaning 15% documentation 10% other duties as assigned