cGMP Cleaning Technician II - ATRF in Frederick, MD

Description

PROGRAM DESCRIPTION:

The Facilities Maintenance and Engineering (FME) mission is to support the NCI at Frederick in their mission to cure cancer and AIDS. FME is responsible for the physical campus - its research laboratory space, administrative space, the infrastructure that supports the buildings, and the landscape that surrounds them. In addition, we are responsible for managing, planning, designing, and construction management of renovations at the FNLCR.

KEY ROLES/RESPONSIBILITIES:

• Complete training by BDP staff in basic understanding of cGMP requirements.
• Be able to read, understand and follow SOP's without exception.
• Be able to perform routine duties in a consistent manner each and every time.
• Be able to accurately and neatly document all work performed in a timely fashion for review by BDP supervisor.
• Be gown qualified annually in order to enter and perform work in ISO 5 areas.
• Be trained and released by safety personnel for the use of PAPR breathing apparatus necessary when cleaning with highly concentrated sporicidal solutions.
• Be able to handle organize workload independently and adjust quickly to changing priorities.  This would include a high workload after a power outage.
• Be proactive and clear in communicating with BDP to relay any observations of potential problems and to assure that mix-ups do not occur.
• Alert supervisor when inventory levels of cleaning and gowning supplies run low so that orders can be placed.
• Be responsible for cleaning throughout the facility to include clean rooms, laboratories, restrooms, warehouse and other areas as needed in order to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices.
• Receive training on specialized equipment will be provided.
• Maintain clean room environment below alert limits by following established cleaning practices
• Clean and wash walls, ceilings, windows (inside and outside) and screens, equipment exteriors, carts, tables, chairs, stools, benches, door handles, door push plates, door latch releases, light switches, telephones, floors, and locker rooms following established aseptic techniques and using appropriate solutions.
• Responsible for preparation of solutions, solution disposal, trash disposal and water collection
• Clean administrative and laboratory areas, including vacuuming rugs and removing stains and foreign matter from a variety of surfaces using proper cleaners.
• Move office furniture and equipment for cleaning.
• Sweep, mop, strip, scrub, wax, and polish floors using industrial power equipment.
• Wash and clean windows and ceiling air vents.
• Dust and clean office areas, woodwork, furniture, floor coverings, fixtures, stairwells, fire doors, and empty trash containers.
• Dispose of biological waste materials. 
• Clean and disinfect restrooms, replenish paper supplies.
• Provide general cleanup outside of buildings.
• Assume responsibility for the inventory and ordering of cleaning equipment and supplies. This is a significant task. This involves coordination with manufacturing staff to anticipate future quantities of cleaning supplies needed without over-ordering and having material expire. The supply chain issues we are experiencing of late factors into this as well. This is a critical duty, failing to have sufficient supplies at all times would most likely result in delays to productions schedules.
• Provide SOP training and to keep training up to date for all cGMP Cleaning Technicians.
• Review and approve completed cleaning documentation. Maintain these records for QA review.
• Be responsible for coordination of staff related to cleaning needs as they arise.
• Coordinate back-up personnel to assist when needed.
• Assume direct responsibility for handling all cleaning request. Become the point person for manufacturing staff and managers to direct cleaning needs/questions.
• Keep track of gowning re-qualification dates for staff.
• Keep track of PAPR filter replacement dates
• The ability to develop, implement and assess performance metrics.
• Assist with leading non-cGMP custodial staff relating to back-up coverage.
• Create, maintain, and distribute reports to update the customer and leadership on the team's progress
• Advanced knowledge in common office applications and word processing software
• Understanding and keeping track of safety practices/trainings

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• High school diploma or GED; Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of two (2) years related cGMP cleaning experience is required.
• Ability to operate industrial power equipment used for cleaning
• Ability to pass aseptic gowning validation
• Ability to read, understand, and follow SOPs
• Proficient in troubleshooting techniques to solve machine issues
• Excellent mathematical skills and strong attention to detail
• Ability to be a team player due to constant interactions with similar employees and stakeholders
• Must have the ability to routinely lift and carry up to 50 lbs.; climb stairs and ladders; work involves bending, stooping, and working in confined areas; potential exposure to particulates, vapors, or noisy environment
• Ability to obtain and maintain a security clearance
• Shift Monday - Friday, 4:00am – 12:30pm, weekend work may be required

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• GMP cleaning experience and respiratory protection training
• Ability to handle and organize workload independently and adjust quickly to changing priorities; this would include a high workload after a power outage
• Ability to perform routine duties in a consistent manner each and every time
• Ability to be a team player due to constant interactions with similar employees and stakeholders
• Ability to operate industrial power equipment used for cleaning
• Proficient in troubleshooting techniques to solve machine issues
• Strong attention to detail

JOB HAZARDS

This position may require continuous or intermittent exposure to and exertion in environmental conditions such as working outdoors, temperature extremes, humidity extremes. etc. as part of the job.