Steve Pendleton

Quality Assurance Manager (Client Support) @Catalent

Bloomington, IN, US
MOBILE NUMBERS
+13•••••••76

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WORK HISTORY

Jul 2022 — Present

Quality Assurance Manager (Client Support) @Catalent

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Bloomington, IN, US

Management of QA Client Support teams responsible for Customer Complaint Investigations, Quality Agreements, New Product Assessments, and Change Requests.

EDUCATION

1995 — 1999

University of Indianapolis

Bachelor of Science (BS), Secondary Education and Teaching

SKILLS

IsoPharmaceutical IndustrySopFdaCathetersLean ManufacturingBiotechnologyProduct DevelopmentTechnology TransferRoot Cause AnalysisQuality SystemV&VSurgical InstrumentsRegulatory AffairsProcess SimulationDrug DeliveryIso 13485Cleaning Validation21 Cfr Part 11Regulatory RequirementsSix SigmaProduct LaunchQuality AuditingAseptic ProcessingChemistryBiomedical EngineeringMinitabCommercializationCapital EquipmentQuality AssuranceDesign for ManufacturingQuality ControlGmpInjection MoldingR&DDesign ControlTechnical WritingLeadershipValidationCross-Functional Team Leadership

ABOUT STEVE PENDLETON

Continuous Improvement in medical device manufacturing & quality environment.Specialties: Coaching & leading others, communication, technical writing, & Lean Six Sigma.

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