Marcia has over 24 years of combined QA and QC experience in the Pharmaceutical and Biotechnology industry.  Areas of expertise include:

• Quality System Development
• Nonconformance and CAPA Programs
• Failure Investigation
• Quality Improvement Initiatives
• GXP Auditing
• Inspectional Preparation
• GXP Training
• ISO Development and Training
• Medical Quality Audits

Marcia’s experience spans both small-scale clinical manufacturing as well as large commercial manufacturing facilities including companies such as Geneva Pharmaceuticals, Somatogen, and Amgen. She has special expertise in assisting organizations to define, establish and execute quality expectations within their facility. She works closely with Operations and Quality organizations to ensure both functional areas work in unity towards a compliant facility while providing sufficient operational flexibility.

Maija has over 16 years of clinical and commercial quality control, regulatory compliance and product development experience in the biotechnology industry.  Professional areas of expertise include:

• GMP System development, implementation, auditing and gap analysis
• Batch record review and approval
• Analytical method development, qualification and validation
• Specification development and justification
• Laboratory design and start-up
• Regulatory document review
• Pre-licensing inspection preparation

Maija has extensive commercialization experience and is very knowledgeable regarding current regulatory requirements. She has been a significant contributor to the commercialization of the approved biotechnology products Enbrel® for rheumatoid arthritis and Vectibix® for metastatic colorectal cancer. Her clinical product experience includes monoclonal antibodies, soluble receptors, fusion proteins and small molecules.

Maija holds a B.S. degree in Molecular and Cellular Biology and Biochemistry from Western Washington University and is located in the greater Seattle area.

Ms. Taylor has over twenty-three years of healthcare industry experience in regulatory affairs, product development, quality control, quality assurance, and manufacturing disciplines with an in-depth knowledge of product development requirements for pharmaceuticals, medical devices, and combination products.

David is a quality professional with 20 years of pharmaceutical and biotechnology experience with both startup and established companies.

David’s industry experience has made him proficient at developing and delivering training programs, developing and executing validation protocols, conducting internal and external audits, and evaluating and implementing quality systems.

David is able to balance company goals with customer needs and safety while satisfying organizational values and applicable regulations. He is adept at communicating with a diverse work force.

In addition to his industry experience, Marv has over 22 years experience with the FDA. As an FDA investigator, Marv specialized in cGMP, Quality System Regulation, and PMA inspections of domestic and foreign medical device manufacturers. He routinely conducted PAI and cGMP inspections of pharmaceutical manufacturers.

From an industry perspective, Marv was a Corporate Compliance and QA auditor at Amgen in Thousand Oaks, California for five years. He performed internal audits at Amgen facilities worldwide and audits of contract manufacturers and suppliers.

Marv has created and presented numerous training classes throughout his career.

Kristen has over ten years of health care industry experience in Solid Dose Pharmaceutical Manufacturing and Quality Assurance. Her experience includes:

• Auditing
• Annual Product Reviews
• SOP and Quality Manual Preparation
• Nonconformance Investigations and CAPA Programs
• Product Recalls
• Document Control Organization

Brianna Information under construction