GMP Supervisor at Cushman & Wakefield in Norton, Massachusetts

Job Description:

Job Title
GMP Supervisor



Job Description Summary

This position requires strict adherence to current Good Manufacturing Practices (cGMP), established cleaning practices and procedures, and compliance with quality standards and regulations. The purpose of the 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 cGMP environment. Supervising union staff to complete the sanitization. This position may require working non-standards shifts (swing) and/or on Saturday or Sunday. The incumbent may be required to work weekends, holidays, and overtime if required. This is a full time, exempt position, overtime eligible.
Job Description



Essential Functions:

• Monday-Friday (3rd Shift, 7:00pm-3:30am)


• Pay: $25hr


• Provide oversight to the union sanitization crew


• Must be able to perform sanitization activities


• Responsible to train new staff


• Ensure technicians adhere to SOP and sanitization practices


• Provide guidance (technical, quality, compliance) to the union crew


• Reviews cleaning log daily to ensure technician adhere to GDP


• Responsible for verifying that the proper sanitization disinfectant rotation is followed, and that the proper sanitization disinfectant is used for each assignment


• Responsible for completing required cGMP documentation to ensure records are properly and accurately maintained


• Responsible for general sanitization supplies, working directly with the cGMP coordinator


• Responsible for organization and upkeep of sanitization supply areas


• Responsible to participate in cycle counting and inventory of sanitization supplies and gowning articles to maintain inventory properly stocked for daily sanitization.

Other Responsibilities Include:

• Collaborate with Manufacturing, Facilities Management, and Janitorial teams to manage schedules necessary to sanitize the cGMP-controlled environment and support areas to comply with cGMP requirements.


• Participate in required training on the use of sanitization disinfectants and equipment


• Understands and follows proper procedures with Environmental Health and Safety (EHS) and personal protective equipment (PPE)


• Act as a backup for cGMP staff.


• Performs related duties as assigned

Skills In:

• Accurate cGMP documentation and sign off on work performed with an emphasis on Good Documentation Practices (GDPs)


• 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 maintaining 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)


• Company policies and practices, including safety rules and regulations

Education and/or Experience:

• High School Diploma or equivalent


• Prior experience on a biopharmaceutical cGMP-controlled environment.


• English usage, spelling and punctuation


• Business computer applications


• Attention to detail is required


• Excellent attendance record


• Must be able to follow work instructions

Physical Requirements and Working Environment:

• No make-up, nail polish, and/or jewelry may be worn in the cGMP process areas


• 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 workday


• Majority of time spent in cleanroom, fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles and/or face shield


• Perform sanitization activities with ceiling mops, wall mops, floor mops, and wipers

#INDCWS


C&W Services is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, protected veteran status or any other characteristic protected by law.


In compliance with the Americans with Disabilities Act Amendments Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a position at Cushman & Wakefield, please call the ADA line at 1-888-365-5406 or email HRServices@cushwake.com . Please refer to the job title and job location when you contact us.


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