Joann Christensen Email & Phone Number

Los Angeles, California, United States

Sioux Falls, South Dakota, United States

Manage internal and external supplier audit program.

Sioux Falls, South Dakota

-Perform Apheresis Center and CLIA Cell Processing Lab qualification GMP/GTP/GDP audits for internal and external biotherapies clients for clinical studies adhering to specific clinical protocols-Write audit reports for internal clients and external biotech clients-Issue Supplier Corrective Action Reports (SCARs/CAPAs)-Develop site relationships-Review client specific study protocols-Review patient records for compliance to study protocols-Extensive domestic and… Show more -Perform Apheresis Center and CLIA Cell Processing Lab qualification GMP/GTP/GDP audits for internal and external biotherapies clients for clinical studies adhering to specific clinical protocols-Write audit reports for internal clients and external biotech clients-Issue Supplier Corrective Action Reports (SCARs/CAPAs)-Develop site relationships-Review client specific study protocols-Review patient records for compliance to study protocols-Extensive domestic and international travel Show less

Sarasota, Florida

-Certificate of Foreign Government registrations (CFGs)-Foreign Country Registration (Japan, Saudi Arabia, South America, Russia, Ukraine, South Korea)-SmartSolve, Visio, MS Office Suite-CAPA review-Change Control

Columbia Heights, Mn

CAPA ResolutionSupplier surveysMS Office, Visio

Fridley, Mn

*Learning Management System Integration*Training design* Manage corrective and preventive action activities to ensure that established timelines are met and robust solutions are implemented. * Provides expertise and guidance to Neuromodulation organization in interpreting government regulations, agency guidelines and internal policies to assure compliance. * Support Process Owners with changes to standard operating procedures, work instructions and/or Forms to ensure effective… Show more *Learning Management System Integration*Training design* Manage corrective and preventive action activities to ensure that established timelines are met and robust solutions are implemented. * Provides expertise and guidance to Neuromodulation organization in interpreting government regulations, agency guidelines and internal policies to assure compliance. * Support Process Owners with changes to standard operating procedures, work instructions and/or Forms to ensure effective implementation of requirements. * Supports the development of QS policies, procedures, tools, systems and training programs and interpretation of regulatory and Medtronic requirements. Show less

Remote Contract Employee Based Outside Of Tampa Fl.

-ISO Train Learning Management System integration-Investigations regarding product complaints and CAPAs-Trackwise-Change Control

Minnetonka, Mn

-Medical imaging software/CT and MRI scanning-Maintained 99% compliance with corporate wide training-Expert in Microsoft Office; Microsoft Word, Microsoft Excel, Microsoft Powerpoint, JIRA, AGILE, VISIO-Managed the technical training function and support document control.-Managed the audit function-Internal Quality Auditor, Supplier Management-Reviewed and released design docs, marketing material, and related controlled documentation.-Write Device Master… Show more -Medical imaging software/CT and MRI scanning-Maintained 99% compliance with corporate wide training-Expert in Microsoft Office; Microsoft Word, Microsoft Excel, Microsoft Powerpoint, JIRA, AGILE, VISIO-Managed the technical training function and support document control.-Managed the audit function-Internal Quality Auditor, Supplier Management-Reviewed and released design docs, marketing material, and related controlled documentation.-Write Device Master Records (DMRs) and Device History Files (DHFs)-Supported product release activities-Participate in continual optimization of quality system processes and documentation-Participated with ISO recertification audits-Assist with 510K submissions-Agile Project Management-Change Control Show less

Plymouth, Mn

-Develop training for internal staff-Conducted external supplier audits-Batch record review and product release-Monitor corrective actions-Monitor and maintain status of vendor and supplier qualifications-GFSI Interaction-SQF Audits-Develop and lead investigational activities-Review and initiate SOP changes-Resolve open issues-Resolve product complaints-Label review and approval-Work with supply chain and supplier qualification

Plymouth, Mn

-Managed the Corporate Training Function-Created elearning options using Lectora software-Participated in the selection and implementation of a learning management system for worldwide operations which included software validation-International training provided for all European locations-Responsible for change including training and communication for HR, ISO 13485, quality and safety training requirements-Responsible for regulated training program administration (FDA,… Show more -Managed the Corporate Training Function-Created elearning options using Lectora software-Participated in the selection and implementation of a learning management system for worldwide operations which included software validation-International training provided for all European locations-Responsible for change including training and communication for HR, ISO 13485, quality and safety training requirements-Responsible for regulated training program administration (FDA, AMTAC)-Conducted New Employee Orientation-Designed and delivered corporate wide safety training programs -Conducted Code of Conduct Training-Coordinated volunteer efforts for American Heart Association which resulted in nearly $60,000 for AHA-MS Office, Cobent, SharePoint Show less

Eden Prairie, Minnesota

Managed club including spa and equipment, sales tours, financial daily close-outs. I worked part-time in addition to my full-time job. Interacted with many celebrities and high profile members where confidentiality was essential.

-Responsible for FDA regulated training program design and administration in the injectable drug industry-pharmaceutical industry-New employee orientation-Internal audits-Reviewed batch product results for accuracy and safety

Bachelor Of Science, Agricultural Education/Biological Sciences

Completed pre-med level biology, chemistry, organic chemistry, and physics.

M.Ed, Training And Development/Vocational Ed.

Activities and Societies: Graduate Assistant-Department of Agricultural Engineering Minnesota Extension Service

Mba, Business Administration With Focus In Manufacturing Systems Engineering

Master Of Business Administration - Mba