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The Aseptic Support Supervisor is responsible for overseeing aseptic support operations within a 503B outsourcing facility, ensuring compliant execution of production activities that meet FDA, cGMP, and internal quality standards. This role provides daily leadership to aseptic support, staging, and coordination teams to ensure safe, accurate, and timely preparation of materials used in sterile manufacturing.
Job Responsibility:
Supervise aseptic support, staging support, and coordinator operations
Review operator adherence to HR policies and perform disciplinary action when necessary
Approve electronic time keeping for reports
Manage personnel to operational standards and complete performance evaluations
Partner with the new product development team to ensure components and batch records are ready to maintain adherence to the schedule
Review and maintain adherence to the manufacturing schedules
Aid in inventory control by ensuring personnel are properly documenting and consuming components and material in an ERP system
Track employee training to ensure compliance
Aid in bi-annual reviews of procedures
Provide on-the-floor leadership to the operational team
Ensure safety is followed with equipment, and certifications are up to date
Works with FSS2 staff to oversee transfers from FSS2 to FSS1
Requirements:
Demonstrated knowledge of cGMP pharmaceutical manufacturing, sterile production environments, and 503B regulatory expectations
Previous supervisory or lead experience in cleanroom, aseptic, or pharmaceutical operations preferred
Strong understanding of documentation practices, ERP systems, and material flow in regulated manufacturing environments
What we offer:
Competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry