Aseptic Core Monitor

About Us

Since 1990, we've grown into a global leader in personalized medicine. Today, our 5,000+ energetic employees are based in over 80 locations across Europe, North America, South America, Africa, and Asia-Pacific, working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics, we deliver smart, ready-to-use solutions that make healthcare better. We're passionate, science-driven, and always looking for new ways to improve lives.

About the Role

The Aseptic Core Monitor reports to the Aseptic Quality Senior Specialist and works closely with Operations personnel, Environmental Monitoring, and the Aseptic Quality Specialist during all aseptic production activities. This role is responsible for completing aseptic audits, addressing quality-related questions during manufacturing, and working with the AQ Specialist to manage unplanned events within controlled areas. The Aseptic Core Monitor collaborates with production teams to restore controlled states through communication and coordination across multiple departments, minimizing impact on production schedules.

Responsibilities

• Identify and report QA events related to maintaining aseptic conditions in clean rooms, with a focus on Sterility Assurance during manufacturing operations.
• Ensure timely and accurate process review of batch records and QA checks within the manufacturing process.
• Actively coach, audit, and communicate within Aseptic Processing Areas for the majority of the shift.
• Maintain aseptic gown training and serve as an extension of quality and training in aseptic areas to monitor and reinforce best aseptic practices.
• Assist in generating procedures related to Aseptic Quality functions and activities.
• Maintain compliance with FDA 503B and cGMP guidelines, as well as state and federal laws.
• Assist in developing policies and procedures related to Aseptic Quality.
• Promptly communicate with Operations regarding personnel aseptic techniques, behaviors, complaints, product issues, and variances.
• Gather, organize, and analyze data to develop compliant solutions and alternative methods.
• Assist CAPA teams and other project teams in developing action plans and implementing deliverables.
• Conduct periodic internal reviews or audits to ensure procedures are followed.
• Lead and organize remediation activities for day-to-day unplanned events or shutdown activities.
• Lead, coach, and mentor personnel on aseptic techniques and practices during smoke studies and audits.
• Correct and communicate proper aseptic techniques as needed and escalate corrected behaviors to supervisors.

Requirements

• High School Diploma with a BS/BA degree or 3 years of manufacturing experience.
• Minimum 2 years of pharmaceutical experience with a focus on quality/compliance.
• Ability to multi-task, communicate effectively, and demonstrate critical thinking.
• Oversight of operations with a focus on Sterility Assurance.
• Knowledge of QMS and CAPA-related tools or systems is preferred.
• Experience with environmental monitoring, aseptic processing, or production audits is preferred.
• Experience with inspections and inspection readiness activities is preferred.

Benefits

• Competitive salaries.
• 401(k) plan with company matching contribution.
• Medical, vision, and dental coverage.
• Health Savings Account (HSA).
• Holiday and paid time off.

At Fagron, you'll find opportunities for personal and professional growth in an open, dynamic environment where your ideas and talents can shine.