Kyle Rifenbery
Manager, Microbiology at Bausch & Lomb
- Role
- Manager, Qc Microbiology at 博士伦
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
About Kyle Rifenbery
Quality Control Manager with 14 years of experience in regulated manufacturing environments with an emphasis in Microbiological Testing and Environmental Monitoring supporting sterile manufacturing operations. Demonstrated ability leading QC laboratory operations ensuring appropriate metrics are established and attained to deliver on project milestones and business objectives. Experience with dietary supplements and a variety of pharmaceuticals including sterile injectables (liquid and lyophilized) and ophthalmics (solutions, suspensions, and ointments).
Experience
Manager, Qc Microbiology
Nov 2021 — Present · Tampa, FL, US
Serve as Manager of the QC Microbiology department leading a team of 43 Microbiology Analysts in support of sterile manufacturing operations for ophthalmic solutions, suspensions, and ointments • Responsibilities: o Oversight of routine and non-routine microbiological laboratory testing/personnel ensuring established timelines are met while maintaining quality/right-first-time (sterility, bioburden, bacterial endotoxin, antibiotic assay, antimicrobial effectiveness, particulate matter, biological indicators, growth promotion, identifications, etc.) o Oversight of Environmental Monitoring activities/personnel across 3 shifts 7 days/week including viable and total particulate testing in cleanrooms (Grade A, B, C, D) to understand facility state of control o Oversight/approval of investigations related to laboratory data and environmental monitoring data ensuring appropriate investigative principles are deployed to identify root cause/impact and implement effective CAPAs o Oversight/approval of reporting and trending of laboratory data and environmental monitoring data including monthly, quarterly, and annual reporting and discussions with stakeholders o Establishment, implementation, maintenance, and communication of department metrics related to safety, quality, delivery, cost, and personnel o Oversight of the Aseptic gowning program including routine monitoring of Aseptic personnel gowns, initial qualifications, and re-qualifications o Participation in local, corporate, and regulatory inspections as the Microbiology subject matter expert (SME)
Education
Whitworth University
Bachelor of Science (B.S.), Biology, General
2004 — 2008
Ephrata High School
High School Diploma
2000 — 2004
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