Michael Pilkinton Email & Phone Number

HIGHLY ACCOMPLISHED SENIOR QUALITY CONTROL / ASSURANCE LEADER who excels within complex and challenging cGMP environments while making sound decisions to align with a company’s forward-thinking mission.INFLUENTIAL STRATEGIST who champions the delivery of impactful results while serving as a “go-to” Subject Matter Expert (SME) dedicated to training, coaching, mentoring, and / or qualifying peers and newly hired staff.ARTICULATE COMMUNICATOR who tackles issues via strong critical thinking and problem-solving abilities, as well as sharp attention to detail, while ensuring compliance with cGMP, GLP, GDP, and data integrity regulations.--------------------------------------CAREER HIGHLIGHTS INCLUDE:• Contributing proven leadership experience in method validation and batch testing.• Exhibiting abilities in analytical testing, method transfer / validation, and lab operations.• Driving analysis of raw materials, APIs, in-process samples, stability studies, and finished products.• Coordinating 10 staff to ensure activities were performed for coalition of new product test methods.• Collaborating with Quality Control teams to relocate equipment after an on-site disaster, including serving as approver for protocols and reports, as well as ensuring all parameters were addressed.• Performing key calibrations within Dr. Reddy’s Laboratory, including training, coaching, and mentoring a newly hired Equipment Manager on how to perform calibrations.--------------------------------------SPECIALIZATIONS INCLUDE:Quality Control • Strategic Analysis, Planning & Testing • Regulatory ComplianceQuality Assurance • Risk Assessment & Mitigation • CAPA • Change Management SystemsQMS • IQ / OQ / PQ Protocols • SOPs • Audits • OOS / OOT Reports • Policy DevelopmentTeam Building, Training & Leadership • Method Validation • Batch Testing • GMP • GLP • GDPData Integrity • Instrument Repairs, Calibration & Qualifications (IOPQ) • Process Optimization--------------------------------------TECHNOLOGICAL SKILLS INCLUDE:Conductivity • TOC • KF (LabX Software) • Coulometric Titration Wet Chemistry • PSD • BD • TD • Viscometer • Sieve Analysis • DisintegrationMinitab Software for Statistical Analysis of Product Trending • Melting Point • TLCUPLC • HPLC (Waters, Agilent, OpenLab) • GC • UV • FTIR (ChemStation, Spectrum ES)SAP • Veriteq • Integrin • Microsoft Office Suite • Microsoft Teams • Microsoft SharePointDissolution Apparatus I / II / III / IV • Manual & Automated Sampling • Dissolution Workstation Software

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  Lsu Shreveport

  Bachelor Of Science In Biology