Position Summary:

The Sterile Compounding Technician is a cross-functional production role responsible for both hands-on sterile compounding activities and the cleanroom support work required to maintain safe, compliant operations. The position prepares, fills, inspects, labels, transfers, and documents sterile products while also supporting cleaning and environmental and personnel monitoring within ISO 7 and ISO 5 areas. All work is performed in accordance with approved formulations, standard operating procedures (SOPs), current good manufacturing practices (cGMP), applicable USP 797 requirements, and site quality standards.

Essential Duties and Responsibilities

The essential functions include, but are not limited to, the following:

Sterile Compounding

• Prepare sterile pharmaceutical products according to approved formulations, batch records, and SOPs.
• Apply aseptic technique and contamination-control practices throughout sterile compounding operations.
• Measure, calculate, and mix ingredients accurately, with careful attention to identity, quantity, sequence, and process requirements.
• Complete required line-clearance, setup, in-process, and post-process activities within the assigned cleanroom area.

Compounding Support

• Assist compounders with preparation and execution of sterile compounding activities by staging materials, preparing equipment, and ensuring required supplies are available and properly sanitized.
• Support workflow within ISO 7 and ISO 5 cleanroom environments by transferring materials, replenishing supplies, and maintaining organized work areas to facilitate efficient production.
• Assist with line clearance, setup, and post-production activities to ensure compounding operations are completed safely, accurately, and in compliance with established procedures.
• Communicate production needs, material shortages, equipment issues, and quality concerns to compounders and supervisors in a timely manner.

Filling and Repackaging

• Set up and operate approved filling equipment to place sterile pharmaceutical products into the appropriate containers accurately and safely.
• Perform filling, packaging, and repackaging activities in accordance with approved procedures and regulatory requirements.
• Monitor equipment and process conditions, and promptly report deviations, malfunctions, or quality concerns.

Cleanroom Cleaning and Readiness

• Prepare and maintain the sterile compounding environment in a state of control and operational readiness.
• Perform and assist with daily, weekly, monthly, and event-driven cleaning and disinfection within the compounding environment.
• Use approved cleaning agents, tools, contact times, and cleaning sequences; document chemicals, activities, dates, times, and other required information.
• Adhere strictly to gowning, hygiene, material-flow, and cleanroom behavior requirements.

Material Transfer

• Safely transfer components, supplies, equipment, waste, and finished materials into, within, and out of ISO 7 and ISO 5 cleanroom spaces.
• Follow approved sanitization, staging, segregation, and transfer procedures to minimize contamination and mix-up risks.
• Document material movements and maintain required traceability.

Documentation and Monitoring

• Complete production, cleaning, transfer, inspection, monitoring, and other required records contemporaneously, accurately, and legibly.
• Perform environmental and personnel monitoring within ISO 7 and ISO 5 cleanroom spaces as trained and authorized.
• Follow data-integrity requirements and promptly communicate errors, discrepancies, excursions, or deviations.
• Support investigations, corrective actions, training, and continuous-improvement activities as assigned.

Team and Compliance Responsibilities

• Follow all safety, quality, compliance, and security requirements and all applicable SOPs.
• Maintain required training and qualifications for assigned compounding and cleanroom support tasks.
• Collaborate with Production, Quality, Operations, and other departments to meet scheduling and quality objectives.
• Perform other job-related duties and assignments as directed by authorized personnel.

Minimum Qualifications (Knowledge, Skills, and Abilities)

Required Qualifications:

• High school diploma or equivalent.
• Strong attention to detail and a demonstrated commitment to quality, patient safety, and regulatory compliance.
• Ability to complete a thorough training and qualification program and consistently follow SOPs and quality standards.
• Ability to learn and apply aseptic technique, cleanroom protocols, cGMP documentation practices, and applicable USP 797 requirements.
• Effective teamwork, communication, organization, and time-management skills.
• Strong discipline and reliability when performing repetitive, highly controlled work.

Preferred Qualifications

• Working knowledge of USP 797, cGMP regulations, and cleanroom operations.
• Experience in sterile compounding, pharmaceutical manufacturing, or another highly regulated environment.
• Current or eligible Arkansas Pharmacy Technician license.

Physical Demands and Work Environment

Working Conditions:

• Work in a controlled cleanroom environment with strict gowning, hygiene, and conduct requirements.
• Stand and work in confined or small cleanroom spaces for extended periods.
• Lift, push, and pull up to 40 pounds.
• Perform repetitive motions and detailed tasks while wearing required personal protective equipment.