Malinda Kambs

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Malinda Kambs graduated from Rockford College with a bachelor’s degree in chemistry and has accumulated 20+ years as a Quality Assurance professional within the cGXP industry. Her experience encompasses the pharmaceutical, biopharmaceutical, and medical device industries.

Her Expertise Includes:

• Quality Systems program development and implementation 
• Design and implementation of Manufacturing Process transfer program from clinical scale to commercial manufacturing
• Cleaning Validation Program development and remediation for various drug platforms and industries
• Process Validation Program development and remediation for various drug platforms and industries
• Shipping Validation Program development
• Stability Program development
• Analytical Method development and validation for various drug assays
• Analytical Method transfer program development
• Auditing of supplier and contract manufacturing facilities
• Development and/or remediation of change control programs
• Equipment/ facilities/ utilities commissioning and qualification

Her Career Experience Includes:

• 6+ years of designing and implementing Quality Management System programs for newly constructed facilities and /or restructuring and improving existing programs that address Change Control Management, CAPA development, Deviation management, Equipment and Facility Qualification, and Supplier Quality Management
• 10+ years designing and implementing quality forward technical transfer plans and scale-up operations in support of growing CDMO portfolios with pending NDA submissions or PAI inspections
• 20+ years of designing, developing, and implementing multiple Cleaning Validation and Process Validation Programs 
• 18+ years evaluating and remediating validation programs for companies responding to the issuance of an FDA consent decree or NOIR notification
• 15+ years representing the Validation Department as the Validation Subject Matter Expert (SME) during FDA, LRQA, PAI, and customer audits
• 6+ years of Validation/Calibration Departmental Management
• 5+ years of QC analytical method validation and method transfer execution

Her Manufacturing Process Validation Experience Includes:

• Aseptic pharmaceutical formulation, bulking, filtration, filling, and labeling
• Plasma fractionation, protein recovery, purification, pasteurization, filtration, filling, lyophilization, and capping
• API manufacturing 
• Monoclonal antibody manufacturing, purification, and cellular coating. 
• Antigen-specific reagent red blood cell manufacturing, purification, filling, labeling, and shipping
• Medical Device manufacturing 
• Animal Heath manufacturing