Work Schedule

Monday - Thursday, 10AM - 8PM

FLSA Status

Non-exempt

Salary

Starting at $20/hour based on experience plus twice a year bonuses

Summary

A Pharmaceutical Cleaner Sanitizer plays a crucial role in maintaining the highly controlled environments required for pharmaceutical manufacturing. The Cleaner Sanitizer is responsible for maintaining a meticulously clean and sterile environment within the manufacturing areas, ensuring compliance with strict regulations and contributing to product quality and safety. This involves properly following detailed cleaning procedures and protocols to minimize contamination risks.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Must be able to aseptic gown, demonstrate aseptic technique and pass annual gown qualifications.
• Perform routine cleaning and sanitization of rooms, surfaces, equipment, and tools within designated areas such as clean rooms, storage areas, controlled environments and other manufacturing processing areas.
• Follow established protocols and standard operating procedures (SOPs) for cleaning and sanitization.
• Ensure compliance with Good Manufacturing Practices (GMPs) and ISO standards.
• Maintain accurate records of cleaning times, chemicals used, and other relevant data, practicing Good Documentation Practices (GDocPs). Ensure all documentation completed is Attributable, Legible, Contemporaneous, Original, and Accurate in accordance with ALCOA principles and GDocPs.
• Empty trash, manage waste receptacles, and handle hazardous or biohazard materials appropriately.
• Assist in setting up manufacturing operations as needed.
• Disassemble, clean, sanitize, and reassemble processing equipment as needed.
• All equipment should be set up and operated in a proper manner. Any wear or damage to equipment or parts should be immediately escalated to management prior to using the equipment.
• Must have or gain a basic understanding of room environments and parameters, such as temperature and humidity, escalate any events outside standards to supervision.
• Document all cleaning activities, observations, and deviations from SOPs as required by policies and procedures.
• Adhere to all sanitation procedures and regulatory requirements (e.g., FDA).
• Wear appropriate Personal Protective Equipment (PPE) as required.
• Properly and carefully follow procedures for cleaning up spills and other contamination events.
• Handle cleaning chemicals safely, including understanding dilution and usage procedures.
• Troubleshoot and resolve operational issues related to clean room activities.
• Monitor and replenish inventory of cleaning supplies and chemicals as needed.
• Responsibilities include exhibiting training competency while performing all required cleaning, sanitizing and support tasks.
• May be involved in training new employees on clean room procedures.
• Potentially assist in other areas such as supporting manufacturing operations or coordinating with other teams.
• May need to move materials and equipment to access and clean designated areas.

Other Duties and Responsibilities

• Daily activities and assigned tasks should always be performed in a safe and efficient manner.
• All unusual, non-routine occurrences when performing tasks (NOE report) should be immediately reported and escalated to management.
• May be asked to assist in the development or revisions of Standard Operating Procedures (SOP), master batch records or other relevant cGMP documentation.
• Adhere to all company dress code attire, jewelry policy and proper protective equipment (PPE) requirements. Maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas)
• Attend training classes, workshops, meetings, etc., as required to contribute as a subject matter expert (SME) for investigations, remediation, process optimization or improve job skills.
• Actively participate in shift changeover, handoff sessions when and where applicable.
• May be asked to participate in other Manufacturing Operations not listed on a need basis.

Required Education and Experience

• Highly regulated GMP cleaning requires a high degree of attention to detail to ensure all areas are thoroughly cleaned and sanitized.
• Prior cleaning and sanitizing experience in a heavily regulated environment such as the pharmaceutical industry is preferred.
• Prior training and knowledge of GMP / GDocP is preferred. Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
• Minimum high school diploma or general education degree (GED)
• Must be willing and able to work in controlled environments with both small and large machinery
• Must possess strong verbal, written, and oral communication skills
• Must be able to work independently and with a team
• Ability to recognize priorities and actively make productive use of time to build operational efficiencies
• Must exhibit punctuality and low absenteeism

Competencies

• Detail Oriented
• Meticulous
• Communication
• Organizational Skills
• Problem Solving/Analysis
• Results Driven
• Technical Capacity

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Able to stand, walk, sit, bend or reach, 8-10 hours or more per day as needed
• May need to lift or maneuver up to 50 pounds on occasion

Position Type and Expected Hours of Work

This is a full-time position. Monday - Thursday 10AM-8PM. Because of the nature of the business, work schedules may vary at times.

Travel

No travel is expected for this position.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.