GMP Cleaner - 3rd Shift

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The GMP Cleaner will be responsible for ensuring the cleanliness and sanitation of our parenteral drug manufacturing facility, following strict Good Manufacturing Practices (GMP) guidelines. The successful candidate will work as part of a team dedicated to maintaining a sterile environment to meet regulatory requirements and ensure the quality of our pharmaceutical products. ### Responsibilities - Cleanroom Maintenance: Perform daily cleaning and disinfection of cleanrooms, including floors, walls, ceilings, and equipment, following GMP Standard Operating Procedures (SOPs). - Sterile Equipment Cleaning: Clean and sanitize manufacturing equipment and utensils used in the production process, ensuring they are free from contaminants. - Waste Management: Properly manage and dispose of waste generated in the manufacturing facility in compliance with GMP guidelines and safety protocols. - Gowning: Adhere to strict gowning procedures, ensuring personal hygiene and cleanliness to prevent contamination within the facility. - Documentation: Maintain accurate records of cleaning activities, environmental monitoring results, and report any deviations from standard procedures. - Chemical Usage: Handle and store cleaning chemicals safely and in accordance with safety data sheets (SDS) and GMP requirements. - Collaboration: Collaborate with the Quality Assurance team to address any cleanliness-related non-conformities and participate in investigations to identify root causes. - Continuous Improvement: Identify and suggest improvements in cleaning processes and contribute to the development of new cleaning procedures and protocols. - Safety: comply with all safety rules, regulations, and best practices to maintain a safe work environment. ### Qualifications - High school diploma or equivalent. - Previous experience in a GMP-regulated environment or pharmaceutical manufacturing facility is a plus. - Knowledge of GMP guidelines and cleanroom practices is highly desirable. - Strong communication and documentation skills. - Ability to work as part of a team and follow strict procedures. - Willingness to undergo gowning and cleanroom training. ### Shift 3rd shift: 11:00pm - 7:30am , Sunday - Thursday