Senior Quality Systems Auditor

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Senior Quality Systems Auditor
Responsibilities: Auditing, schedules, plans, conducts, and leads audits in accordance with the Corporate QS Audit Program. Acts as a subject matter expert. Ensures audit activities are in compliance with company procedures and regulatory requirements. Disseminates audit findings to senior management as required by the Corporate QS Audit Program. Provides extensive regulatory expertise as needed to support QS improvement initiatives. Develops and creates audit reports, coordinates action plans, and follow up with auditee to assure prompt and adequate completion of agreed upon actions. Establishes and conducts sectional readiness training for FMC RTG sites and QS functions. Serves as GMP subject matter expert (SME) for regulatory inspections, as needed. Creates, revises, develops, and reviews standard operating procedures used for GMP auditing. Performs any other tasks as requested by Management to support quality oversight activities. Helps development and reporting of quality and compliance metrics related to Compliance audit activities. Leads contracted 3rd party audit activities used for supporting the Corporate QS Audit Program. Coaches/mentors staff as a means to ensure performance and professional development. Establishes/maintains effective cross-functional team communications to advance FMC quality activities. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. Assists with various projects as assigned by a direct supervisor.

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