Candidate will work as a Quality Supervisor on 2nd Shift, overseeing Manufacturing Quality, Environmental Monitoring and Batch Release personnel. This position is responsible for quality activities on 2nd shift. Manufacturing Quality is responsible for manufacturing support/audits, visual inspection and label/pack AQL audits as well as document review. Environmental Monitoring is responsible for the sampling of the cleanroom areas, incubation of plates, documentation of results, initiation of events for out of specification results, document review and data entry. Batch Release is responsible for the issuance and review of batch records for commercial release. This position will oversee all activities as well as working with Production and Post-Production leadership in the resolution of issues that arise. This position will work with the 1st shift counterparts for shift passdown of information and issues.
• Manage direct reports – Lead and coach team under direction of the Quality Manager/Director, driving a high-performance organizational culture.
• Oversee MQ, EM and Batch Release activities on 2nd shift to ensure coverage of work. • Crosstrain group to cover all areas of activity.
• Work with Production and Post-Production to address any issues that arise. Effectively work to resolve issues in a timely manner and ensure deviations are initiated as needed.
• Work with 1st shift counterparts for effective passdown of information is received for any priorities or ongoing issues that need to be addressed.
• Communicate effectively between all groups to ensure proper information is received and given.
• Openly communicate any issues to manager or director.
• Effectively determine priorities to ensure coverage is available when needed.
• Review events and deviations in MasterControl for completeness and disposition these accordingly.
• Compile data for trending tracking or reporting.
• Maintain training compliance for self and team.
• Review and approve documents, including master batch records, label revisions, printed labels, forms, change controls, SOPs, etc.
• Maintain inspection ready procedures and participate in internal and customer audits and inspections.
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• Bachelor’s Degree, preferably in a scientific field or a high school diploma with previous supervisory experience in pharmaceuticals
• 5 years of pharmaceutical or healthcare related experience
• Previous supervisory experience preferred
• Good written and verbal communication skills
• Good leadership skills with previous leadership experience preferred
• Ability to work interdepartmentally and communicate effectively with various departments
• Good organizational skills and good attention to detail • Ability to work in a fast pace environment while keeping patient safety and product quality as a first priority
• Ability to train team members in the various quality processes
• Understanding of 503b, 21 CFR Part 11, 210 and 211 requirements
• Ability to drive continuous improvement for compliance and processes
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.