Gareth Storm is a highly qualified expert, that works in Ngm Biopharmaceuticals main office of which is in 1092. as a Senior Manager Quality Systems from 2020. Gareth Storm has earned professional experience in more than 17 positions at various companies. Gareth Storm went to the Los Angeles Pierce College and UC Riverside and was studying. This professional has the following qualifications: Iso 9001:2008 and Iso 13485 Lead Internal Auditor. Oakland, California is the area, where this expert was known to live. Gareth's phone and email are easily accessed through SoftwareOfficial on demand.
Name variants:
Gareth Storm
Last updated May 16, 2024
Contact Information
Last Update
Feb 1, 2016
Email
ga**@chiron.com, gs**@medrio.com
Location
Oakland, CA
Company
Workplace
Colleagues
Work History
Senior Manager Quality Systems
333 Oyster Point Blvd, South San Francisco, CA 94080
from Apr 2020
Quality System Specialist
West Des Moines, IA
Manage, monitor, and improve the quality system for a variety of pharmaceutical and medical device firms under GMP/QSR, ISO 13485, and EU regulations. Create and maintain quality systems, ma...
Oct 2016 — Jun 2017
Quality Manager
521 Cottonwood Dr SUITE 121, Milpitas, CA 95035
Responsible for all aspects of Quality Assurance for an emerging medical device manufacturer, including document control, training, internal audits, CAPA, deviations and nonconforming materi...
Nov 2015 — Sep 2016
Quality Systems Manager
345 California St SUITE 325, San Francisco, CA 94104
Manage all aspects of the Quality System and act as Management Representative at an EDC software company serving clinical trials. Create and support a GCP-based quality system in compliance ...
Apr 2011 — Mar 2015
Qa Specialist
920 Harvest Dr SUITE 200, Blue Bell, PA 19422
Maintain Quality System in an audit-ready state through creation and review of procedures, records, and other controlled documents at all levels of the organization to assure consistency, a...
Aug 2009 — Jun 2010
Sr. QA Specialist
In collaboration with all functional areas, wrote, reviewed, and revised standard operating procedures, forms, and other controlled documents using the full Microsoft Office Suite.
Performed...
Dec 2005 — Jun 2009
Senior Qa Specialist
In collaboration with all functional areas, wrote, reviewed, and revised standard operating procedures, forms, and other controlled documents using the full Microsoft Office Suite.
Perform...
Dec 2005 — Jun 2009
Regulatory Operations Associate Ii
Performed detailed review of documents supplied for submissions for accuracy, completeness, traceability, and suitability for the submission being made.
Assembled and published paper and h...
Sep 2004 — Aug 2005
Regulatory Compliance Associate
Emeryville, CA
Created, modified, and delivered over a dozen training courses in various media regarding quality assurance, regulatory compliance, documentation, and other GxP topics.
Authored and revise...
Feb 2003 — Nov 2003
Qa Document Specialist
Responsible for review, revision, change control and filing for about 200 SOPs, manufacturing records, controlled forms and labels, and other controlled documents for all areas. Led a team o...
Apr 2002 — Nov 2002
QA Document Specialist
Responsible for review, revision, change control and filing for about 200 SOPs, manufacturing records, controlled forms and labels, and other controlled documents for all areas.
Led a team o...
Apr 2002 — Nov 2002
Document Specialist
Primary reviewer for regulatory and clinical documents, including content, appearance, filing, and distribution for the Regulatory Affairs and Clinical Operations departments. Assembled, edi...
Feb 2001 — Feb 2002
Technical Writer and Qa Auditor
Authored and revised GMP-compliant SOPs for all areas of the company.
Reviewed documentation regarding manufacturing, plasma collection, and other aspects of the plasma collection and frac...
Feb 1999 — Nov 2000
Director, Actor, Managing Director
Managed theater operations for a nonprofit educational theater organization, as well as directing and acting in plays.
1996 — 2004
QA Compliance Data Coordinator
Reviewed, collected, and analyzed regulatory compliance data on over 200 GMP plasma collection, testing, and storage facilities worldwide.
Assisted Director of QA Compliance in writing respo...
Sep 1992 — Feb 1999
Qa Compliance Data Coordinator
Reviewed, collected, and analyzed regulatory compliance data on over 200 GMP plasma collection, testing, and storage facilities worldwide.
Assisted Director of QA Compliance in writing res...
Sep 1992 — Feb 1999
Education
Occupations
IT Professional
Systems Manager
Representative
Waiter
Host
Sales Specialist
Supplier
Scientist
Biotechnology Professional
Quality Assurance Professional
Computer Systems Administrator
Services Professional
Sales Representative
Biologist
Biological Scientist
Inspector
Skills
Quality Assurance
Validation
Fda
Software Documentation
Quality System
21 Cfr Part 11
Capa
Regulatory Submissions
Document Management
Cross Functional Team Leadership
Clinical Trials
Gmp
Auditing
Quality Auditing
Sop
Quality Management
Regulatory Affairs
Quality Control
Documentation
Change Control
Gxp
Testing
Audit Management
Iso 13485
Iso
Medical Devices
Supplier Quality
Management Review
Computer System Validation
Edc
Quality Systems
Supplier Audits
Continuous Improvement
Data Analysis
Complaint Management
Supplier Evaluation
Process Simulation
Training
Qsr
Cgmp
Complaint Handling
Preventive Actions
Batch Records
Discrepancy Resolution
Internal Audit
U.s. Food and Drug Administration