GMP Operations Cleaning Supervisor

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** GMP Operations Cleaning Supervisor
-JLL (3rd shift, Grave Shifts)
**** What this job involves
- ** The GMP Cleaning Supervisor works in activities associated with the sanitization of controlled areas in accordance with internal procedures, protocols, and cGMP's. The incumbent will follow all applicable standard operation procedures (SOP), guidelines and policies to ensure sanitary conditions are maintained, that appropriate room and equipment sanitization records are neat and accurate, and that professional behavior is displayed within the controlled areas.

The incumbent plays a critical role in assuring sanitary conditions of the controlled areas is maintained to manufacture biopharmaceuticals. This is a full time, on-site, exempt, bonus eligible position. 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.  Manages 8-18 union staff to complete the cleaning. This position may require work on a Saturday and / or a Sunday.  The incumbent may be required to work weekends, holidays and off-shift hours.
** What your day to day will look like:
*** Provide oversight to the union cleaning crew
* Must be able to perform cleaning activities
* Responsible to train new staff
* Ensure technicians adhere to SOP and cleaning practices
* Provide guidance (technical, quality, compliance) to the union cleaning crew
* Providing timely review of all documentation per area relevant SOP’s to ensure technicians adhere to GDP.
* Responsible for reviewing, verifying and archiving cleaning log to client Quality
* Responsible for verifying that the proper sanitization disinfectant rotation is followed and that the proper sanitization disinfectant is used for each cleaning assignment
* Responsible for completing required GMP documentation to ensure records are properly and accurately maintained
* Responsible for overseeing disposal of waste from GMP manufacturing process area waste receptacles on a daily basis
* Responsible for ensuring adequate general sanitization supplies are available to perform necessary cleanings
* Responsible for organization and upkeep of sanitization supply areas
* Collaborate with Manufacturing, GMP Operations Manager, 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 disinfectants and equipment
* Follow cGMPs as outlined in 21 CFR Part 211
* Must pass a gowning qualification test in order to enter and sanitize the GMP process rooms
* Helps control what enters the GMP process areas
* Provides refresher training of sanitization practices as needed.
* Understands and follows proper procedures with Environmental Health and Safety (EHS) and personal protective equipment (PPE)
* Act as a backup to the other Supervisors.
* Performs other related duties as assigned
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* Required Qualifications:

*** Communicating clearly and concisely, both orally and in writing (bilingual a plus)
* Ability to read, write and understand documentation in English
* Ability to work in a team environment and independently
* Establish and maintain a…