Operations PREP Technician II

What Are We 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.

What You Will Do

• 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 MasterControl 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

Who You Are

Wilcrest Pharma is 503B outsourcing facility dedicated to addressing critical gaps in the pharmaceutical industry. Our mission is to deliver high-quality antineoplastic medications and help mitigate drug shortages, enhancing patient care across health systems, clinics, pharmacies, and other healthcare providers.