Collin Wolfe Email & Phone Number

San Marcos, Texas, United States

• Lead a team of Quality Specialists who collaborate to meet an on-time delivery of test results each day, including advanced troubleshooting and problem solving as needed.• Lead a team of Records Management Associates whose primary duties include send-off of positive result notifications, deferral of patients on the National Donor Deferral Registry, and to organize and archive documents processed by the testing facility with off-site storage as needed.• Host audits with regulatory agencies and client organizations as needed including the FDA. • Serve as primary designee for receipt of controlled storage samples at the facility with assessments that the products meet cGMP requirements.• Attend and organize leadership and team meetings.

San Marcos, Texas, United States

• Perform quality review of documents pertaining to test results, QC logs, materials & reagents validation, shipments, equipment, environmental conditions, and any other lab documentation as required.• Work and communicate in a collaborative team with the goal of meeting an on-time delivery of final test results each day, including problem solving, and discrepancy accountability. • Remotely monitor, review, and respond to environmental preventative systems as schedule and issues as needed.• Attend team meetings, correspondence, and workplace training events as needed.• Keep all documentation and job processes within strict adherence of SOPs and cGMP regulations including assistance in third party or internal audits as well as proper archival of documentation.

San Antonio, Texas, United States

• Process biological specimens through viral marker testing assays on ABBOTT PRISM nEXT, ABBOTT Alinity s, and Roche cobas® platforms.• Perform and document routine maintenance, inventory management, reagent validation, and troubleshoot issues as needed for lab instruments.• Ensure compliance with government requirements, hospital policies and laboratory procedures, including maintaining the cleanliness of lab equipment, instruments and work area.• Participating in clinical studies for the ABOTT Alinity s platform and the cobas® 6800/8800 Zika Assay• Train new employees on platforms as required according to Standard Operating Procedures (SOPs) and review employee competencies on platforms as needed.

San Marcos, Texas