Principal QA Consultant

Michele Starsiak holds a Master's degree in Microbiology, and has 25 years QA/QC experience in the pharmaceutical, biotech, cosmetic, OTC, diagnostic and medical device industries including over 10 years of QA/QC and manufacturing management.  She has managed Quality Assurance, multiple QC laboratories, and manufacturing departments resulting in a comprehensive knowledge of the complete pharmaceutical manufacturing process from start to finish.  Prior experience includes development and set-up of quality systems, laboratory controls, manufacturing controls, and warehouse controls for a new cleanroom facility resulting in a positive PAI by FDA.  Audit experience ranges the full gamut from components, excipients, packaging, electronics, API, laboratories, warehouses, 3PL, packagers, manufacturers (cosmetics, OTC, pharma, medical device, invitro diagnostics, biologics), and service providers (PVG, PDMA, complaints, etc.)  

Positions Held

Principal QA Consultant 

Starsiak Consulting, Inc. 

Sr. Manager, Quality Assurance 

Dura Pharmaceuticals, Inc.

Manager, Quality Control   

Dura Pharmaceuticals, Inc.

Manufacturing Manager 

Quidel Corporation

QC Manager

Pacific Biotech, Inc.

QC Microbiologist

Mycogen Corp.

See LinkedIn profile:

http://www.linkedin.com/in/michelestarsiak

QA Consultant Network

Starsiak Consulting utilizes a network of experienced and versatile quality assurance professionals to best fit the client's needs.  QA consultants are available to assist with all QA tasks or projects including manufacturing support, cGMP compliance audits, document preparation and review, validation and all routine QA functions and tasks.

Our Business

Since 2001, we have provided excellent QA consulting services to clients ranging from global pharmaceutical companies to small start-up ventures.

Clients serviced directly or via third parties include:

Valeant Pharmaceuticals

SkinMedica

Xcel Pharmaceuticals

Sangart

Salmedix

Pacific Pharmascience

Favrille

Prometheus

Arena Pharmaceuticals

airPharma

Artes Medical

Reactive Surfaces

MabVax Therapeutics 

ProPharmaCon

Anchen Pharmaceuticals 

Somaxon Pharmaceuticals

Avanir Pharmaceuticals

VMG Partners

Di Salvo Group

Amylin Pharmaceuticals

Nexgen Pharma

MarcasUSA

Orexigen Therapeutics

References available upon request! 

Office:  619-520-5210

 starsiakconsulting@att.net