Quality Assurance Manufacturing

Patrick Navarre ASQ CQA ***** Verba Lane, Guerneville, CA 95446

Phone: 707-***-****

Summary of Qualifications:

Over 15 years of progressive experience in Quality Assurance and

Manufacturing for biopharmaceutical companies.

Experience performing both internal and external audits for regulated

companies

Successfully working with manufacturing to resolve documentation issues and

disposition production batch records in a timely manner.

Coordinate, negotiate and facilitate successful projects on time and on

budget.

Relevant Skills:

batch record generation, review and disposition

Generating and resolving deviation/investigations

Project Management

Team leadership and collaboration

Leveraging professional resources within the organization to expedite

resolution

Compliance monitoring

Review documentation of Validations, SOPs, investigations and analytical

test data

Serve as Person-in-Plant function

Internal and External Auditing

Work History:

Supplier Quality Auditor, Bayer HealthCare. Berkeley, CA

08/06 - 7/19/2010

Prioritize, schedule and execute audits of Bayer HealthCare suppliers and

testing labs which support GMP Manufacturing.

Issue audit reports for external audits performed.

Perform internal compliance audits of Bayer departments which support GMP

Manufacturing.

Senior GMP Auditor, Vaxgen Corporation. South San Francisco, CA 11/05

- 05/06

Prioritize, schedule and execute audits of VaxGen suppliers, testing labs,

clinical sites, and contract manufacturing organizations.

Lead internal compliance audits of VaxGen departments which support GMP

Manufacturing.

Issue audit reports for both internal and external audits performed, and

track follow up actions to closure.

Develop formalized procedures for Vendor Approval and Raw Material

Qualification along with VaxGen's Purchasing and Quality Control

departments.

Manager, Contract Manufacturing, Vaxgen Corporation. South San

Francisco, CA 3/05 - 11/05

Provided oversight of product fill, labeling activities and product

distribution at Vaxgen's Contract Manufacturing Organizations.

Managed contract-manufacturing issues related to multiple clinical trials.

Review and approve validation and production documentation, and facilitate

resolution of production issues in a timely manner

Responsible for scale up of contract manufacturing activities including

development runs, process and equipment validation media fills, and

clinical and commercial manufacturing runs.

Manager, Contract Manufacturing, Corixa Corporation. South San

Francisco, CA 8/01 - 12/04

Hired for quality assurance expertise and overall ability to manage people,

lead teams and facilitate projects.

Provided oversight of product fill, labeling activities and product

distribution at Corixa Contract Manufacturing Organizations. Had first-

line responsibility for Material Review Boards, deviations and

investigations, and External Change Control.

Managed contract-manufacturing issues related to multiple clinical trials.

Performed on-site final batch record review of antibody manufacturing batch

records at Beringer Ingelheim along with Corixa QA.

QA Contract Manufacturing Associate, Genentech, Inc. South San

Francisco, CA 7/99 - 7/01

Provided on-site monitoring and guidance at contract manufacturing sites.

Assured compliance to cGMPs and Genentech standards during production

campaigns.

Served as the primary Quality representative between contract sites and

Genentech.

Authored/revised Standard Operation Procedures and related manufacturing

documents in order to provide a "seamless" interface between Genentech's

and the Contractor's Quality Systems.

Performed technical review of batch records and expedite the closure of

outstanding manufacturing or documentation issues/discrepancies detected

during batch record review.

Participated and/or lead quality investigations related to products

manufactured at contract sites.

Developed and provided annual training at contract sites.

Senior QA Compliance Specialist, Coulter Pharmaceutical South San

Francisco, CA 8/97 - 7/99

Responsible for overseeing, coordinating and performing compliance audit

review of lot history records for all manufactured lots produced at

contract manufacturing and clinical sites.

Generated certificates of analysis, product disposition forms, and all

pertinent documentation to reflect the disposition of material.

Worked closely with contract manufacturing to improve key processes and

documentation.

Provided guidance to contract manufactures as it relates to Biological

License Application (BLA) and Pre-Approval Inspection (PAI) requirements.

Established and maintained electronic database to track product trends,

investigations and deviations on a lot-to-lot basis.

Performed vendor audits as necessary.

QA Inspection and Release Coordinator, Baxter Biotech Hayward, CA

2/91 - 8/97

Performed final product inspection, including labeling, document review,

batch record review, and packaging inspection.

Performed sampling, inspection, and disposition of incoming raw materials,

in-process, and subassembly materials. Disposition included updating

transactions in AS400 system. Performed functional testing of incoming

materials.

Initiated, revised, and obsoleted pertinent documentation. Issued

procedural discrepancy and deviation forms as a quality assurance delegate.

Archived and retrieved both raw material and final product lot retention

samples. Quarantined expired and rejected material. Retested or

dispositioned expired material and verified disposal of rejected material.

Contacted vendors to request Certificates of Analysis, irradiation

sterilization conformation data, and requested changes or updates to

specifications.

Initiated validation protocols and final reports for shipping material with

specific time and temperature requirements.

Quality Assurance Technician II, Gelman Sciences. Ann Arbor, MI

7/86 -10/90

Performed visual and functional testing of incoming materials.

Performed in-process and final lot testing of product based on SPC.

Performed audits of line clearance, machine set-up, and final product

documentation review.

Carried out in-process and final packaging audits.

Education & Training:

Eastern Michigan University, Ypsilanti, MI

BFA., Graphic Design

Certification

American Society for Quality, Certified Quality Auditor

Several industry related courses, seminars and training in: Auditing,

Project Management, cGMP's, Batch Record Review and Investigation,

Sterility Testing, Lyophilization, Fundamentals of Protein Chemistry and

Analytical Biotechnology.

Technical Expertise:

MS Office

MS Project

Visio

Lotus Notes

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