Karen Lopresti

Director of Clinical Qa and Systems

Karen Lopresti is a high-skilled professional, who works in Zogenix main office of which is in 1178. on the position of Director of Clinical Qa and Systems since 2017. Karen Lopresti gained professional experience in more than 13 positions at different companies. Karen Lopresti went to the University of California, Santa Cruz and received education there from 2005 to 2007. Chicago, Illinois is the city, where the professional was known to live. This professional's contacts are easily accessed through Connexy by request.
Name variants:
Karin Lopresti, Karyn Lopresti, Kari Lopresti, Karrie Lopresti

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Contact Information

Last Update
Jul 1, 2022
Email
kl**@chemgenex.com
Location
Chicago, IL
Company

Workplace

Zogenix, Inc.
Director of Clinical Qa and Systems

San Diego, CA

Industry

Pharmaceuticals, Mfg Pharmaceutical Preparations, Pharmaceutical Preparations, Druggists' Goods Merchant Whols

Work History

Director of Clinical Qa and Systems

5959 Horton St, Emeryville, CA 94608
Responsible for all the Clinical programs developmental through Phase 3. Responsible for the entire internal and external audit program, clinical sites and vendor audits for all programs, as...
from Jan 2017

Head of Quality Assurance

8000 Marina Blvd SUITE 300, Brisbane, CA 94005
Create, and grow a compliant and top notch Quality Assurance Department to help provide support and oversight in a highly regulated global environment
May 2015 — Jun 2016

Principal Consultant

Supported medium and small sized pharmaceutical companies in develop and implementation of Quality systems personally suited for the specific needs of the company. From starting from scratch...
Jan 2012 — May 2015

Head of Quality Assurance

California
Lead the development and management of Maxygen’s GCP, GMP, and GLP quality and compliance systems, policies and SOPs, and develop and implement the GxP training program. Implement quality sy...
Oct 2008 — Dec 2011

Head of Quality Assurance

725 San Aleso Ave, Sunnyvale, CA 94085
Lead the development and management of Maxygen’s GCP, GMP, and GLP quality and compliance systems, policies and SOPs, and develop and implement the GxP training program. Implement quality sy...
Nov 2007 — Nov 2008

Senior Compliance Auditor

Illinois
Audit Clinical study sites for all projects for Abbott Vascular, including suppliers, clinical sites, core labs, and all other contracting firms. Audit Abbott’s internal records for all clin...
Oct 2005 — Nov 2007

Cgmp Compliance Manager

Schedule, conduct, and document external and internal GMP, and GLP audits for their Anthrax and Small Pox vaccines. Create and/or revise SOPs and other controlled documents for manufacturing...
Sep 2004 — Jun 2005

Quality Assurance Specialist Iv, Quality Assurance

Batch record review for their cardiovascular and inflammatory disease products Analytical review of Quality Control data for commercial release of product Auditing both internal and exter...
Sep 2003 — Sep 2004

Qa Technical Specialist

Jan 2002 — Sep 2003

Scientist Iii and Stability Coordinator and Microbiology Supervisor

May 2000 — Oct 2001

Developmental Scientist

Participated in the 510K submission to the FDA for a low cost multiuse diagnostic tool to determine if a patient had specific communicable diseases. Development and Design of a fast, solid p...
Aug 1994 — Feb 1999

Research Associate

Formulation and stability of liquid and dry reagents Extensive work with fast and complete rehydration of dry reagents: Capillary flow, filtering systems, mechanical mixing, drying patter...
Apr 1992 — Aug 1994

Chemist Core Development

Designed, executed, and analyzed experiments dealing with Therapeutic drug assays Antibody and enzyme optimization Enzyme conjugation Formulation of serum and synthetic calibrators Feas...
Oct 1989 — Apr 1992

Education

Occupations

Executive
Director
Sales Specialist
Supplier
IT Professional
Software Tester
Operations Manager
Services Professional
Sales Representative
Computer Specialist

Skills

Fda
Sop
Gmp
Clinical Development
Validation
Pharmaceutical Industry
Biotechnology
Gcp
Glp
Capa
Clinical Operations

FAQs about Karen Lopresti

What's the main profession of Karen Lopresti?

This professional's job is Director of Clinical Qa and Systems

What jobs is Karen proficient at at?

Karen Lopresti is proficient at such jobs as Executive and Director.

Where does Karen Lopresti currently live?

Karen lives in Chicago, Illinois.

Does the professional have the email address?

kl**@chemgenex.com is The professional's email address.

Where did Karen Lopresti work?

The expert worked at Zogenix, Aimmune Therapeutics.

What education does Karen Lopresti have?

Karen studied at the University of California, Santa Cruz from 2005 to 2007.

Are there any special industries Karen Lopresti is connected to?

Karen works in Pharmaceuticals industry.

Are there any skills, that Karen Lopresti has?

Karen Lopresti has skills in the following areas: Fda, Sop, Gmp, Clinical Development, Validation, Pharmaceutical Industry, Biotechnology, Gcp, Glp, Capa, and Clinical Operations.
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