Jamie Magnuson Email & Phone Number

St Joseph, Missouri, United States

St. Joseph, Missouri Area

Saint Joseph, Missouri

Greensboro, NC

• Managed a team of ten individuals responsible for Quality Assurance of a non-manufacturing site of over 250 employees, as well as oversight of an external supply organization of contract manufacturers, packagers and.
• Responsible for the implementation of the local quality systems that comply with company standards, local regulations, and all regulations of the respective countries in which the products were marketed in accordance.
• Provided guidance from a QA perspective, to ensure compliance with Novartis and regulatory authority requirements/cGMP for such activities as change management, process/equipment/method validations, process.
• Maintain Quality Agreements with contractors to ensure adherence to Novartis and regulatory authority requirements/cGMP
• Evaluate new or existing contractors, assessing compliance with Novartis and regulatory authority requirements to support development, testing, commercial manufacture, packaging and/or storage of new or existing products
• Ensuring that local quality systems are established that comply with company standards, local regulations and country regulations for those countries where the product is marketed

Tampa, FL

• Managed the production of development, exhibit, clinical trial material and commercial batches of 5 products in differing stages of development through the use of 3rd Party Contract Manufacturers
• Managed the finished goods supply inventory for investigational and commercial drug products
• Primary Manufacturing contact with 3rd Party Contract Manufacturers
• Managed the issuance of purchase orders and purchase requisitions
• Responsible for authoring the Chemistry, Manufacturing, and Controls (CMC) sections for NDA and IND submissions
• Provided on-site management/person in plant (PIP) during manufacture of our products and technical transfer at our 3rd Party Contract Manufacturers

Saint Petersburg, FL

• Author and approver of unplanned and planned deviations related to raw materials, semi-finished and finished goods, equipment, and facilities
• Primary Quality Assurance contact with 3rd Party Contractors in regards to unplanned and planned deviations related to the manufacturing of their products
• Provided instructions to production in response to of production events and unplanned deviations
• Revision to Quality Documents such as SOP’s and Forms
• Responsible for providing Trackwise training to the site
• Local Trackwise Administrator

Lincoln, Nebraska

• Quality Assurance 2002 – 2005
• Managed the batch record review and release of finished goods for two (2) third party customers (Commercial and Non-Commercial Products)
• Master Production and Packaging Record review and approval
• Equipment, Cleaning and Process Validation protocol and report review and approval
• Writing and approval of deviation reports and change control
• Hosting of third party audits