Operations PREP Technician II

What We Are Looking For

The Operations Prep Technician supports sterile and nonsterile drug compounding and manufacturing activities within a 503B outsourcing facility. This position is responsible for preparing equipment, cleanroom areas, materials, components, and chemicals for use in batch production while maintaining strict compliance with company SOPs, current Good Manufacturing Practices, Good Documentation Practices, applicable FDA expectations, and quality system requirements. The role performs shift start-up and close-out activities, maintains complete and accurate records, supports material and component traceability, and promptly escalates discrepancies, deviations, equipment concerns, or potential quality events to management and Quality.

• Prepare, clean, and disinfect materials, components, chemical containers, supplies, and equipment used in sterile and nonsterile drug compounding and batch manufacturing activities within a 503B outsourcing facility.
• Document and maintain accurate inventory and transfer records for materials and components introduced into ISO-classified cleanroom areas.
• Prepare autoclave loads with required components and support sterilization activities in accordance with approved procedures, batch requirements, and quality expectations.
• Use Master Control software or other approved systems to maintain traceability of components, chemicals, devices, and materials sterilized, transferred, or prepared for production.
• Review, complete, and verify cleaning records, logs, and related production records accurately and in accordance with Good Documentation Practices.
• Clean and disinfect cleanroom areas according to approved daily, weekly, and monthly cleaning procedures in coordination with cleanroom operators and production leadership.
• Support tracking, forecasting, staging, and allocation of materials based on production schedules, batch priorities, historical consumption, and operational demand.
• Communicate production needs, material shortages, discrepancies, and quality-related concerns clearly and promptly to Operations and Quality management.
• Comply with company SOPs, current Good Manufacturing Practices, Good Documentation Practices, aseptic processing expectations, contamination-control practices, quality control requirements, and applicable safety standards.
• Support inspection readiness by maintaining clean, organized, accurately documented, and compliant work areas at all times.
• Perform other related duties as assigned, consistent with the scope and requirements of the position.
• Assist with special projects as needed.

• Education:
  
  High School Diploma or equivalent, required
• Experience
  • Previous 1-2 years CGMP/USP or LEAN manufacturing experience, required
• Ability to read, understand, follow, and comply with technical documents, batch records, controlled forms, written instructions, and SOPs.
• Strong attention to detail with the ability to complete production records, cleaning logs, inventory records, and required documentation accurately, legibly, and contemporaneously.
• Working knowledge of sterile and nonsterile compounding, pharmaceutical manufacturing, aseptic operations, cleanroom behavior, contamination control, or regulated production practices preferred.
• Basic understanding of 503B outsourcing facility expectations, cGMP principles, Good Documentation Practices, and quality system requirements preferred.
• Basic computer proficiency, including the ability to use production, inventory, batch record, or traceability systems.
• Ability to communicate professionally and effectively in a team-based manufacturing and quality-driven environment.
• Demonstrated reliability, accountability, and commitment to product quality, patient safety, regulatory compliance, and inspection readiness.
• Ability to follow detailed processing instructions and work consistently in ISO-classified cleanroom and controlled production environments.
• Ability to prioritize tasks, follow production schedules, and respond appropriately to changing operational needs.
• Ability to stand, walk, bend, reach, and perform repetitive tasks for extended periods during assigned shifts.
• Ability to lift, carry, push, or pull up to 40 pounds as needed.
• Ability to wear cleanroom gowning and required personal protective equipment while working in controlled manufacturing environments.
• Experienced with the use of a respirator required.

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