Job Requirements: 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 to work on a Saturday or a Sunday. The incumbent may be required to work weekends, holidays, and overtime if required.
This is a full time, first-shift, exempt position, with overtime eligibility.
Essential Functions: 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 Reviews cleaning log at the end of each shift to ensure technician adhere to GDP Attends Work Center Team and represent the team 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 disposal of waste from GMP manufacturing process area waste receptacles on a daily basis Responsible for general sanitization supplies, works with the GMP Cleaning coordinator Responsible for organization and upkeep of sanitization supply areas Responsible to participate 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, 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 sterile 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 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, (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 of cleaning a biopharmaceutical GMP controlled environment is a plus but not required English usage, spelling, grammar and punctuation 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 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 work day 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 Working in the ancillary support space adjacent to the GMP areas to ensure cleanliness JLL Is an Equal Opportunity Employer JLL is committed to developing and maintaining a diverse workforce. JLL strongly believes in equal opportunity extended to all individuals in all aspects of the employment relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination without regard to race, color, religion, belief, creed, age, sex, pregnancy or maternity (including childbirth and related conditions), family responsibility (e.g. child care, elder care), nationality, ethnic or national origin or ancestry, citizenship, marital status, civil partner status, sexual orientation, gender identity or expression, transgender status, veteran’s status, genetic information, trade union membership, social position, political view or status as a qualified individual with a disability, protected leave status or any other protected characteristic in accordance with applicable law. The company also endeavors to make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodations would impose an undue hardship on the operation of our business and ensures that employment decisions are based only on valid job requirements.