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

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 collaborative working relationships with internal and external customers

• Providing excellent customer service with both internal and external customers

• Knowledge ofCurrent Good Manufacturing Practices (cGMP),Good Documentation Practices (GDP) andCompany 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

Preferred Qualifications:

• Prior experience of cleaning a biopharmaceutical GMP controlled environment is a plus but not required

Location: Oceanside, CA

Shift: Night/Grave shift - Sunday to Thursday or Tuesday to Saturday - 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.

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 the 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

• Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.

This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship.

Estimated compensation for this position:

This range is an estimate and actual compensation may differ. Final compensation packages are determined by various considerations including but not limited to candidate qualifications, location, market conditions, and internal considerations.

Location:

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If this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table!

Personalized benefits that support personal well-being and growth:

JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:

• 401(k) plan with matching company contributions

• Comprehensive Medical, Dental & Vision Care

• Paid parental leave at 100% of salary

• Paid Time Off and Company Holidays

• Early access to earned wages through Daily Pay

At JLL, we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities, we analyze your application for relevant skills, experiences, and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role you'repursuing.

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