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Posted: Sunday, March 12, 2017 11:13 PM

PURPOSEManage daily activities of the quality control microbiology laboratory in support of oral solid dose and novel drug product manufacturing. KEY DUTIES and RESPONSIBILITIESEnsures that all work is conducted according to GMP requirementsEnsures compliance with applicable regulatory guidelines and internal standards through gap assessments and remediationManages the method validation processes for the introduction of R and D materialsApproves technical documentsResolve issues by focusing on root cause determination and implementing effective preventive actionsIdentify and evaluate opportunities for continuous improvementPromotes a team:based environment committed to safety, quality and excellence in executionRepresent the Microbiology Lab during regulatory and internal audits and applies technical expertise in response to related observations EDUCATION/EXPERIENCEBS in Microbiology or related scientific disciplineMin 6 years progressive pharmaceutical QC laboratory experience Min 2 years managerial experienceKnowledge of EMA regulatory guidelines is desiredLEADERSHIP SKILLSAbility to assign work to staff to meet overall departmental goals with the flexibility to respond to urgent business needsAbility to schedule laboratory testing and assign work to maximize efficiency; utilize KPIs and metrics to monitor group performance and determine areas of improvementAbility to assess and improve employee performance through performance management; emphasizing goal setting, development and capability buildingTECHNICAL SKILLSThorough knowledge of compendia USP and ICH guidelines. Expertise in bioburden, TOC, microbial identifications and other related assays is requiredThorough knowledge of USP purified water systems (cold and hot) Expertise in bioburden monitoring programs for utilities such as steam and compressed gasDemonstrated ability to establish and lead Environmental Monitoring program for non:sterile facilityCOMMUNICATION SKILLSTechnical writing skills, including technical and deviation reports, and input into investigations, change controls, SOPA?sAbility to communicate clearly, verbally and in writing, both within and between departmentsRepresents the QC Microbiology Lab on cross:functional teams PROBLEM SOLVINGStrong ability to identify and troubleshoot analytical problemsApplies root cause problem solving skills for identification and implementation of effective corrective and preventive action linkedin


• Location: Cincinnati

• Post ID: 35212918 cincinnati is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017