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Hourly GMP2 Cleaner

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Title:Hourly GMP2 Cleaner


Pay Rate/Range:13.00

Location:Durham, NC

This position requires strict adherence to current Good Manufacturing Practices (cGMPs), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the cleaning and sanitization program is to control microbial contamination and to serve as a corrective action for the loss of control for viable excursion contamination. Standard Operating Procedures (SOPs) must be followed and strictly enforced to ensure acceptable environmental monitoring results of the cleaned GMP environment.
The incumbent may be required to work weekends, holidays, and overtime if needed.
Essential Functions-

  • Responsible for routine daily, weekly, monthly, and quarterly room sanitization in GMP manufacturing process areas
  • Responsible for non-routine sanitization in the GMP manufacturing process areas due to the environmental excursion, process requirements, or facility maintenance and construction
  • Responsible for verifying that the proper sanitization agent rotation is followed and that the appropriate sanitization agent is used for each cleaning assignment
  • Responsible for completing required GMP documentation to ensure records are accurately and adequately maintained contemporaneously
  • Responsible for mixing and disposal of sanitization solutions on a daily basis
  • Responsible for disposal of waste from GMP manufacturing process area waste receptacles on a regular basis
  • Responsible for collecting full, soiled gowning article bags on a daily basis, and replacing with new bags
  • Responsible for ordering general manufacturing supplies such as but not limited to clean room wipes, gloves, face masks, hairnets, shoe covers, cleaning agents, etc.
  • Responsible for stocking and maintaining GMP manufacturing process areas with gloves, face masks, hairnets, laundered and disposable gowning articles, and sanitizing equipment and supplies
  • Responsible for organization and upkeep of sanitization supply areas and general manufacturing supply areas
  • Responsible for organization and distribution of gowning items (laundered and disposable) within the GMP manufacturing process areas on a daily basis to ensure proper inventory levels
  • Responsible for participating in cycle counting and inventory of sanitization supplies and gowning articles in order to maintain inventory levels for timely reordering

Other Responsibilities Include-

  • Collaborate with Manufacturing, Facility, and Quality teams to manage schedules necessary to clean the GMP controlled environment and support areas to comply with GMP requirements
  • Participate in required training on the use of sanitization reagents and equipment
  • Strictly follow Standard Operating Procedures
  • Must pass a sterile gowning qualification test in order to enter and sanitize the GMP filling process rooms
  • Control what enters the GMP process areas
  • Adhere to procedures while performing cleaning and sanitization activities
  • Sanitization activities will be performed with ceiling mops, wall mops, floor mops, and wipers
  • Understands and follows proper solvent handling procedures (EHS) and personal protective equipment (PPE)
  • Performs related duties as assigned

Skills In-

  • Accurate GMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)
  • Communicating clearly and concisely, both orally and in writing
  • Ability to work in a team environment and independently
  • Establish and maintain collaborative working relationships with internal and external customers
  • Providing excellent customer service with both internal and external customers

Knowledge of-

  • Current Good Manufacturing Practices (cGMP) is a plus but not required
  • Good Documentation Practices (GDP) is a plus but not required
  • Company policies and practices, including safety rules and regulation
    Education and/or Experience:
  • High School Diploma or equivalent
  • Prior experience of cleaning a GMP controlled environment is a plus but not required.
  • Business computer hardware and software applications
  • Attention to detail is required
  • Excellent attendance record
  • Must follow work instructions

Physical Requirements and Working Environment:

  • No make-up, nail polish, and/or jewelry may be worn in the GMP process areas
  • The incumbent is subject to extended periods of standing, walking, pushing and pulling, bending and crouching, climbing, and lifting of equipment and/or materials weighing up to 50 pounds
  • Continuous mental and visual attention to manufacturing functions
  • Continuous standing and walking throughout the work day
  • To enter the cleanroom you must be, fully gowned including head covering, face mask, gloves, plant shoes, safety glasses/goggles and/or face shield

Hourly GMP2 Cleaner

Full time
Durham, NC

Published on 11/23/2019