Job Summary
The Aseptic Technician supports cleanroom operations by performing activities that ensure the control and prevention of contamination throughout all stages of pharmaceutical compounding and production. This role assists with the movement of materials and finished goods, environmental monitoring, sanitization, documentation, and general cleanroom support while adhering to all applicable Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and regulatory requirements.
Essential Duties & Responsibilities
Follow all SOPs, cGMPs, batch records, and controlling documentation with strict adherence.
Transfer batch components aseptically between corridors, material transfer rooms, and buffer rooms.
Support buffer room personnel by staging and delivering supplies during production.
Perform routine daily, weekly, and monthly sanitization of cleanroom and drug storage areas.
Conduct environmental and personnel monitoring as required.
Inspect components for package integrity and quality.
Verify, document, and track expiration dates of supplies.
Assist with setup, calibration, operation, and monitoring of equipment per SOPs.
Maintain equipment, parts, and supply inventory within ERP systems and paper logs.
Complete documentation clearly and accurately in accordance with Good Documentation Practices (GDP).
Complete required training within established timelines and assist with training of new team members as needed.
Exhibit dependable attendance, punctuality, and flexibility in scheduling.
Perform other duties as assigned.
Education & Experience
High school diploma or GED required (or in process).
Some prior work experience preferred.
Experience with sterile compounding practices is a plus.
Knowledge, Skills & Abilities
High attention to detail and ability to work in a fast-paced environment.
Basic computer proficiency and ability to learn new software systems.
Ability to understand and operate production and monitoring equipment.
Must be able to pass gowning, gloving, personnel monitoring, and visualization testing after training.
Ability to pass initial and annual eye exams for color blindness and visual acuity.
Capable of wearing required personal protective equipment (PPE) including masks, gloves, gowns, hairnets, and eye protection.
Physical Requirements
Stand for extended periods; walk frequently throughout work areas.
Lift, carry, push, and pull up to 40 pounds (occasionally more with assistance).
Bend, kneel, reach, climb ladders, and perform fine motor handling tasks.
Visual acuity required for inspection activities.
Frequent verbal communication and ability to hear instructions and alarms.
Working Conditions
Work is performed in an indoor, controlled cleanroom environment.
Exposure to sanitizing agents, sporicidal chemicals, and pharmaceutical compounds (some hazardous).
Noise level is typically moderate.
Workplace & Cleanroom Conduct Expectations
Production and Quality Unit team members must wear scrubs as their work uniform and change into cleanroom-dedicated scrubs prior to entering the cleanroom.
Hair cover, beard cover (if applicable), mask, and facility-dedicated shoes are required. Socks and undergarments must be worn at all times.
No jewelry, makeup, nail polish, artificial nails, fragrances, hair products, or wet hair permitted in the cleanroom.
Electronic devices with camera or recording capability are prohibited unless authorized.
Team members must wash or sanitize hands prior to cleanroom entry.
Closed-toe shoes are required outside of office areas.
Team members must maintain a neat, clean, and professional appearance.
Individuals with certain medical conditions (e.g., active illness, open wounds, recent tattoos with visible abrasion) may be restricted from cleanroom entry.
Cell phone and personal device use must not interfere with job duties and should be limited during work hours.