This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
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
Requirements:
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 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), Good Documentation Practices (GDP) and Company policies and practices, including safety rules and regulations
Attention to detail is required
Excellent attendance record
Must follow work instructions
High School Diploma or equivalent
Nice to have:
Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus but not required