Laura Morgan

Associate Director, QA at Acucela Inc.

Location
Greater Seattle Area
Industry
Biotechnology

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Laura Morgan's Overview

Current
Past
  • Senior Manager Quality Assurance at Amgen Inc
  • Quality Assurance at Amgen
  • Quality Assurance Compliance Supervisor at Immunex Corporation
  • Senior Quality Assurance Compliance Associate at Immunex Corporation
  • Quality Assurance Associate at NeoRx Corporation
  • Senior Quality Assurance Coordinator at NeoRx Corporation
  • Product Security Coordinator/Technologist I/II at NeoRx Corporation
Education
Connections

216 connections

Laura Morgan's Summary

Quality Assurance professional with diverse experience in the quality support function for all phases of clinical trial biologics manufacturing. Worked at a Fortune 100 international firm as well as small startup biotechnology companies. Creation and application of phase appropriate quality systems, verbal and written communication, problem solving, regulatory inspection support and audit performance. Proven ability to lead teams of creative professionals to achieve both strategic and tactical solutions.

Specialties

Calibration, GLP/GMP documentation, filemaker pro, regulatory compliance, inventory management, microsoft access, microsoft excel, microsoft outlook, microsoft powerpoint, microsoft word, Maximo, written and verbal communication, validation protocols and reports, quality assurance, strategic and tactical decision making

Laura Morgan's Experience

Associate Director, QA

Acucela Inc.

Public Company; 51-200 employees; Biotechnology industry

December 2009Present (4 years 11 months)

Developing a phase appropriate quality assurance program for Acucela.

Senior Manager Quality Assurance

Amgen Inc

Public Company; 10,001+ employees; AMGN; Biotechnology industry

July 2002July 2009 (7 years 1 month)

-Coordinated project proposal to clarify document requirements for clinical production records leading to improved right first time documentation.
-Composed and received approval for six (6) quality system standards in Amgen’s document hierarchy that ensured consistent application of US and EU regulations across Amgen’s clinical operations.
-Developed monthly work force metrics to provide senior management with real-time work force capability.
-Revised document periodic review program reducing cost by 70%.
-Implemented monthly document review backlog metrics and reports reducing backlog by 20% monthly.
-Supported Amgen’s goal of successful government agency inspections resulting in continuing clinical operations and facility licensing.
-Managed documentation work stream to decommission Bothell Clinical Operations with successful on-time completion. Team was successful in archiving 13,000 records, obsolescing 700 documents and changing ownership of 400 documents.

Quality Assurance

Amgen

Public Company; 10,001+ employees; AMGN; Biotechnology industry

July 2002July 2009 (7 years 1 month)

Quality Assurance Compliance Supervisor

Immunex Corporation

Public Company; 1001-5000 employees; IMNX; Biotechnology industry

October 2000July 2002 (1 year 10 months)

Senior Quality Assurance Compliance Associate

Immunex Corporation

Public Company; 1001-5000 employees; IMNX; Biotechnology industry

May 1999October 2000 (1 year 6 months)

Quality Assurance Associate

NeoRx Corporation

Public Company; 51-200 employees; Biotechnology industry

November 1996May 1999 (2 years 7 months)

Senior Quality Assurance Coordinator

NeoRx Corporation

Public Company; 51-200 employees; Biotechnology industry

April 1992November 1996 (4 years 8 months)

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Product Security Coordinator/Technologist I/II

NeoRx Corporation

Public Company; 51-200 employees; Biotechnology industry

August 1987April 1992 (4 years 9 months)

Laura Morgan's Education

Linfield College

BA, Biology

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