Gerald Maquera

Director of Quality Assurance @Thermo Fisher Scientific

Madison, WI, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2021 — Present

Director of Quality Assurance @Thermo Fisher Scientific

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Middleton, WI, US

EDUCATION

1988

UW-Milwaukee at Waukesha

Associate of Science - AS, Chemistry

1991

Southern Adventist University

BS, Biology

SKILLS

Quality Management21 Cfr Part 11CRORegulatory RequirementsStandard Operating Procedure (Sop)MicrobiologyLife SciencesBiotechnologyGood Laboratory Practice (Glp)Pharmaceutical IndustrySopFdaValidationCapaLimsLaboratory SkillsLaboratoryDrug DevelopmentGcpBiopharmaceuticalsGlpUspHplcQuality SystemTechnology TransferHigh-Performance Liquid Chromatography (Hplc)Quality ControlGmpPharmaceuticsGxpQuality AuditingQuality AssuranceChemistryRegulatory SubmissionsChange ControlRU.s. Food and Drug Administration (Fda)Regulatory AffairsAnalytical ChemistryChromatography

ABOUT GERALD MAQUERA

Experienced Quality Assurance professional with 20+ years of experience and a proven track record in achieving operational efficiencies, cost savings and expert process improvement and change management methodologies. Experienced in regulatory inspections from FDA, PDMA and government agencies from both the U.S. and EU. Strong focus on risk-based auditing with success in high-volume output, timely deliveries, and low external inspection/audit observations Passionate about driving results through strong leadership and professional development for a highly skilled team to exceed client expectations. Areas of Expertise: Quality Assurance, Regulatory Inspections, Laboratory Testing (GLP), Manufacturing (GMP/EU GMP), Medical Devices, Facility Management, Process Audits, Data Management, Equipment Safety & Function, Reporting, Vendor Management, Lean Six Sigma, Performance Management, and Coaching & Mentoring Industry Experience: Pharmaceuticals, Manufacturing, and Life Sciences Feel free to reach out to me directly on LinkedIn or at m•••••••@yahoo.com.

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Gerald Maquera — Director of Quality Assurance at Thermo Fisher Scientific in Madison, WI, US | Unifers