Scientist II, Method Introduction & Support (MI&S)

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Job Description

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About the role:

Plan, develop, lead and evaluate improvement and compliance projects relating to assay method validation/remediation, and Analytical Instrument Qualification. Responsible for basic project management and documentation authoring (e.g. protocols and reports). Provide technical expertise and/or support investigation teams in troubleshooting/problem solving activities as applicable. Provide recommendations for decisions of test systems and results of moderate complexity. Self-led individual that works under minimal supervision to meet deadlines/goals.

How you will contribute:

• Lead ongoing assay validation/remediation daily department activities across all shifts for the Biochemistry and Microbiology Laboratory including supervision of assigned personnel when performing assays and when required assist other Quality areas in the successful performance of these activities.
• Develop test procedures, generate protocols, reports and other documentation to support method/equipment revisions and validation.
• Lead and drive Analytical Instrument Lifecycle projects including qualification, relocation, decommissioning, risk assessments, and periodic reviews.
• Own and drive quality processes, investigations, and actions for change controls, deviations, and CAPAs.
• Author more complex technical assessments to assist investigations and problem solving
• Develop, establish and monitor systems that focus on key indicators of assay performance including laboratory control trends and data analytics.
• Be directly involved in ...

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