Judy Helser
Site Regulatory Compliance Expert @Agilent Technologies
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WORK HISTORY
Site Regulatory Compliance Expert @Agilent Technologies
Boulder, CO
EDUCATION
South Dakota State University
B.S.
ABOUT JUDY HELSER
Quality professional with extensive experience in medical device, pharmaceutical, and biopharmaceutical industries. Strong foundation in Quality Assurance, Quality Systems, Quality Compliance, validation, Quality Engineering, and 21 CFR Part 11. Record of successful interaction with Federal and International regulators (including ISO) and corporate auditors, including FDA biennials. Experience managing teams with direct and indirect reporting structures. Regulatory inspection readiness, training, and management (FDA, EMA, ANVISA, TGA, PMDA, TFDA, TMoH, COFEPRIS and ISO). Certified auditor (ASQ; Certified Quality Auditor); trained 6 Sigma Black Belt (Becton Dickinson / Juran Institute); Registered Microbiologist (ASM; Clinical and Public Health). Specialties: Quality systems, regulatory inspection management, lead auditor, GMP, QSR, ISO, inspection readiness and responses, Quality Engineering
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