Aseptic Process Simulation Program Coordinator
About this role
Aseptic Process Simulation Program Coordinator
Job Description The APS/Media Fill Program Lead for a sterile ophthalmic manufacturing site in Waco, TX, leads the site-wide program in alignment with current GMP, FDA, EU Annex 1, and AbbVie quality standards, developing and executing the annual strategy, overseeing protocols and documentation, coordinating cross-functional execution, and serving as the subject matter expert for investigations and inspection readiness. The role also covers trend analysis, personnel qualification integration, CAPA and continuous improvement, regulatory and customer-audit support, technical leadership, mentorship, and monitoring industry and regulatory developments to strengthen contamination control and aseptic operations.
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