Fagron · 1 day ago
Aseptic Core Monitor - 1st Shift
Wichita, KS
Full-time
Onsite
Entry, Mid Level
2+ years expFagron is the global market leader in pharmaceutical medicine, dedicated to improving medications and helping patients. The Aseptic Core Monitor is responsible for ensuring compliance with aseptic conditions during manufacturing, conducting audits, and collaborating with various departments to maintain quality standards.
BiotechnologyHealth CareMedicalPharmaceutical
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 Monitor’s 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
Qualification
Required
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
Preferred
Knowledge of QMS and CAPA related tools or systems
Environmental monitoring, Aseptic Processing or production audit experience
Experience with inspections and inspection readiness activities
Benefits
Competitive salary
Comprehensive benefits
Performance package
Company
Fagron
Fagron is committed to the personalization of health treatment to cover the individual patient’s need through Pharmaceutical Compounding & Sterile Outsourcing Services.
1001-5000 employees
H1B Sponsorship
Fagron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$464.09MKey Investors
PGIM
2025-11-24Post Ipo Debt· $225M
2016-03-02Post Ipo Equity· $239.09M
2007-10-05IPO
Leadership Team
Rafael Padilla
CEO
Karin de Jong
CFO
Recent News
Company data provided by crunchbase