Description
Job Title: QC Microbiology SupervisorPurpose & Scope:
The purpose of this position is to supervise staff, product testing and Environmental Monitoring data within the QC Microbiology department in support of clinical manufacturing. The role will act as a technical expert within the organization with extensive knowledge related to aseptic procedure and compendial testing. The position will contribute high level data and review for IND submission and release of Phase I, Phase II clinical material.
Essential Job Responsibilities:
Schedule daily staff activities including Environmental Monitoring, WFI and product testing
Review internal lab data
Author and review system/method validation protocols per current compendial guidances (USP, EP)
Conduct DR investigations and implement effective CAPAs
Compile meaningful metrics related to testing
Serve as an aseptic subject matter expert
Provide Microbial ID expertise
Review product COA results and provide IND guidance as they relate to Microbiology testing
Provide Performance Management guidance for scientists to set up annual and future goals
Recruit and hire scientists
Quantitative Dimensions:
Significant role in timely product release including review of data and reporting to QA. Rapid response to facility environmental excursions which impact manufacturing quality and timelines.
Organizational Context:
This position will report to the QC Microbiology Manager within the Quality department.
This position will have 3-5 direct reports ranging from QC Microbiologist ISenior Microbiologist
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