GMP Cleaner - 3rd Shift

August Bioservices; Tennessee; On-site; USD 18,000 - 23,000; Full time

Job summary

August Bioservices in Nashville, TN is seeking a GMP Cleaner to maintain cleanliness of our parenteral drug manufacturing facility in compliance with GMP and regulatory requirements. You will perform daily cleaning of cleanrooms, sanitize equipment, manage waste, follow gowning procedures, and document activities.

The role offers a 3rd shift from 11:00pm to 7:30am, Sunday through Thursday, and a culture focused on quality and continuous improvement.

Qualifications

• Knowledge of GMP guidelines and cleanroom practices required.
• Strong documentation and communication skills required.
• Ability to follow strict procedures and work as part of a team.

Responsibilities

• Cleanroom Maintenance: daily cleaning and disinfection of cleanrooms per SOPs.
• Sterile Equipment Cleaning: sanitize manufacturing equipment and utensils.
• Waste Management: dispose of waste per GMP guidelines and safety protocols.
• Gowning: follow strict gowning procedures to prevent contamination.
• Documentation: maintain records of cleaning activities and deviations.
• Chemical Usage: handle cleaning chemicals safely per SDS and GMP.
• Collaboration: work with QA on non-conformities and investigations.
• Continuous Improvement: suggest improvements to cleaning processes and protocols.
• Safety: adhere to safety rules and maintain a safe work environment.

Skills

GMP knowledge

Cleanroom experience

Documentation skills

Team player

Education

High school diploma

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

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule - from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.