GMP Cleaning and Sanitization Group Leader

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life science engineering and technical solutions MTG has the knowledge and experience to ensure compliance with pharmaceutical biotechnology and medical device safety and efficacy guidelines. With offices in Caguas Puerto Rico and Boston United States we serve life sciences clients in six global markets: United States Puerto Rico Dominican Republic Mexico Germany Canada and South America.

TheGMPCleaning andSanitization Group Leader will assist the Supervisor in ensuring all the cleaning activities are completed intimelymanner in accordancetotheassigned client facilitiesstandards and SOP and cGMP requirements.

Responsibilities:

• Ensure the assigned team keepsclientsite/facilities assigned areasclean and in an organized mannerby safely using approved cleaning chemicals.

• Monitor supplies and chemicals as needed which includes weekly and monthly inventories and ensuring minimum and maximum levels.

• Leada staffand communicate effectively train and monitorworkactivities of thecleaning andsanitation team to maximize personnel safety and working group and complianceconcerns tothe Supervisor.

• Ensure the team is following the cleanliness of the GMP facility in accordance withCleaning andSanitation SOPsand deliver corrective feedback and follow up promptly.

• Assist the Supervisor in performing regular building inspections regardingcleaning andsanitization activities.

• Ensure the assigned staff followed the process to removetrashgarbage from facilities and place them inproperrecycling system.

• Maintains master scheduling of cleaning task/assignments.

• Monitors cleaning logs against scheduled and non-scheduled work orders.

• May attend GMP cleaning update work streams and represent the team as required by the client.

• Responsible for monitoring cleaning logs work request.

• Responsible to participate in cycle counting and inventory ofcleaning andsanitization suppliesin order tomaintain inventory levels for timely the appropriate personnel theordering general sanitization supplies.

• Supports client request toschedulesextra cleaning in the GMP controlled environment.

• Participate in required training associated with GMP cleaning for job responsibility familiarity.

• Understands and follows proper procedures (EHS) and personal protective equipment (PPE).

• Will also be responsible for documenting and entering data into applicable GMP forms.

• Must learn and comply with safety guidelinesGLP andcGMPs/CFRs whichincludes butisnot limited to the maintenance of training records written procedures andlog books.

• Performs related duties as assigned

• Serve as back-up to Quality Control Environmental Sampling / Monitoring Activities (refer to Job Description).

Qualifications Requirements/Knowledge/Education/Skills:

• Bachelors degree OR Associatesdegree & 4 years of directly related experiencein cleaning and sanitation role; a minimum of 3 years in Manufacturing/Pharmaceutical IndustryOR High school diploma / GED & 6 years of directly related experiencein cleaning and sanitation role; a minimum of 3 years in Manufacturing/Pharmaceutical Industry.

• Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus.

• Demonstrated strong leadership skills.

• Experience inCurrent Good Manufacturing Practices (cGMP)andGood Documentation Practices (GDP) isrequired.

• Computer SoftwareSkills:Microsoft office (Word ExcelOutlook)Beginner.

• Work independently as well as in a team environment with the flexibility to work shifts as scheduled (weekends holidays if required)

• Excellent interpersonal and communication

• The COVID-19 vaccine is / may be a condition of employment.

Physical Requirements and Working Environment:

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

• Ability to fully gowned including head covering facemask gloves plant shoes safety glasses/goggles and/or face shield.

• Ability to wear PPE face covers forpandemicscompliance when required.

• Ability to work in an environment where cleaning products are used (i.e. bleach isopropyl sporicidaland other disinfectants)

• Perform moderately physical activities forup2-3 hours and the ability to lift 25 lbs.

• Ability to wear full face respiratory protection including PAPR as applicable.

Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment regardless of race color religion sex sexual orientation gender identity genetic information national origin protected veteran status state disability or any other group protected by law.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.