Aseptic Core Monitor (1st Shift)

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 and addressing any quality-related questions during manufacturing.

Responsibilities

• Identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Conduct 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 be an extension of quality and training within the 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/state and federal laws.
• Assist in developing policies and procedures related to Aseptic Quality.
• Promptly communicate with Operations regarding personnel aseptic techniques and behaviors, complaints, product issues/variances.
• Gather, organize, and analyze data to develop solutions and alternative methods of proceeding compliantly.
• Assist CAPA teams and other project teams in the development of action plans and implementation of deliverables.
• Conduct periodic internal reviews or audits to ensure that procedures are followed.
• Lead and organize remediation activities from day-to-day unplanned events or shutdown activities.
• Lead, coach, and mentor personnel on aseptic techniques and practices when executing smoke studies, audits during manufacturing activities.

Qualifications

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

Benefits

Fagron offers its associates competitive salaries and a wide range of benefits, including a 401(k) plan with a company matching contribution, medical, vision, and dental, health savings account (HSA), and holiday/paid time off.