Cleanroom Operations & Compliance Associate

BioHorizons; Northern (KY); Hybrid; USD 36,000 - 48,000; Full time

Benefits offered by this job

Medical insurance

401k with matching

Paid time off

Vision benefits

Dental insurance

Life Insurance

Parental leave

Casual dress code

Company events

Job summary

BioHorizons seeks an Operations Associate to support cleanroom operations, regulatory compliance, and documentation. You will operate automated machinery, assemble and package medical devices, and ensure traceability through proper labeling and Manufacturing Orders.

Role emphasizes adherence to Quality Management System, PPE, and a safe regulated environment, offering cross-functional collaboration and process improvement within a production setting.

Qualifications

• High School Diploma or equivalent; 2 years of production/shop experience preferred.
• Experience in a cleanroom environment and PPE protocols.
• Medical device manufacturing experience is preferred.
• Detail orientation and ability to follow work instructions within a structured environment.

Responsibilities

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations.
• Operate process equipment, including automated machinery and label printers.
• Assemble and package medical devices.
• Maintain product traceability and documentation for Manufacturing Orders.
• Assist in shutdowns and events that affect operations.
• Support engineering troubleshooting and other tasks impacting operations.
• Maintain a safe, compliant work environment and adhere to Quality Management System.

Skills

Detail oriented

Follow directions

Independent worker

PPE compliance

Education

High School Diploma

Tools

Excel

Microsoft Office

Job description

BioHorizons seeks an Operations Associate to support cleanroom operations, regulatory compliance, and documentation. You will operate automated machinery, assemble and package medical devices, and ensure traceability through proper labeling and Manufacturing Orders.

Role emphasizes adherence to Quality Management System, PPE, and a safe regulated environment, offering cross-functional collaboration and process improvement within a production setting.