Aseptic Core Monitor

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13619404

## Who We Are

Since 1990, weve grown into a global leader in personalized medicine.

Today, our 5,000 energetic employees are based in 80 locations in

Europe, North America, South America, Africa and Asia-Pacificand are

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.

Were passionate, science-driven, and always looking for new ways to

improve lives. ??

Explore your future at[Fagron Career

Site](https://fagron.jobsmarket.site/pages/en-gb/jobs).

## About the Job

The Aseptic Core Monitor reports to the Aseptic Quality Senior

Specialist. This role works closely with Operations personnel,

Environmental Monitoring and the Aseptic Quality Specialist during all

aseptic production activities. Aseptic Core Monitor will be responsible

for completing aseptic audits and addressing any quality related

questions during manufacturing. Aseptic Core Monitor will work closely

with the AQ Specialist to address all unplanned events within the

controlled areas that may require remediation or interventions to be

executed. Aseptic Core Monitor will work alongside production to return

event to a controlled state through communication and coordination of

multiple departments to reduce impact of productions schedule.

**Key Responsibilities**

• Ability to identify and report on QA events related to maintenance
  
  

of aseptic conditions within clean rooms with a focus on Sterility

Assurance during manufacturing operations.

• Responsible for timely and accurate process review of batch records
  
  

and QA checks within the manufacturing process.

• Aseptic Core Monitors primary role is actively coaching, auditing,
  
  

and communicating within Aseptic Processing Areas for the majority

of shift. Must 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
  
  

/ activities.

• Maintain compliance with FDA 503B and cGMP guidelines / state and
  
  

federal laws.

• Assists in developing policies and procedures related to Aseptic
  
  

Quality.

• Promptly communicates with Operations regarding personnel aseptic
  
  

techniques and behaviors, complaints, product issues/variances.

• Gather, organize & analyze data to develop solutions & 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 study, audits during manufacturing activities.

Correcting and communicating proper aseptic technique when needed

and communicating with supervisors as needed on corrected behaviors.

## Basic 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
  
  

preferred.

## What\'s on O fer?

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); holiday/paid

time off.

At Fagron, youll find plenty of chances to grow both personally and

professionally. We work in an open, dynamic environment where your ideas

and talents can shine.

## Ready for the challenge?

Were proud to be an equal opportunity employer. ?? Diversity makes us

stronger, and were committed to creating an inclusive workplace where

everyone feels welcome.\

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Fagron US is committed to creating a diverse environment and is proud to