Carla Olson Email & Phone Number

Verona, Wi, Us

Madison, Wisconsin, United States

• Assist in audit preparation and reconciliation• Facilitate Biennial SOP reviews• Facilitate Client Batch Record Creation/Modifications/Approvals• Issue and Archive Batch Records/Testing Data Capture Sheets/Lab Books/Equipment Logbooks/Room Logbooks/Quality system event documents• Maintain DCR/Quality system event databases and Master Documents/List• Maintain Designated Satellite Areas for controlled paper-based record management system• Maintain Document/Material/Batch Numbering Logs• Manage Record/Document Filing system• Obsolete Documents• Proof and edit document changes including minor SOP updates, if necessary• Write and develop QA SOPs

Greater Madison Area

• Entertain a crowd of 20-100+ patrons• Handle payment from restaurants• Host a weekly pub-style trivia show at various restaurants in the Dane County area• Keep accurate records of team scores

Madison, Wisconsin, United States

• FDA/ISO – regulated, cGMP medical device manufacturer• Assist with FDA inspections and ISO audits• Assist with record retention processes• Maintain document control metrics, quality records, and databases• Manage document control using EtQ Reliance• Perform internal and supplier audits• Provide user training for document control system• Support record retention program• Validate changes made to EtQ Reliance

I sold Jamberry nail and hand products via social media, vendor events, and home parties.

Madison, Wisconsin Area

• Entertained a crowd of 20-100+ patrons• Handled payment from customers• Hosted a weekly pub-style trivia show at various restaurants in the Dane County area• Kept accurate records of team scores

Stoughton, Wi

• Coordinated testing requests with other Cummins sites worldwide• Compiled and presented test results to Engineering personnel• Prepared prototype air filtration products for testing

Verona, Wi

• ISO – regulated, plastics contract manufacturer• Completed calibration/verification for all types of measuring devices• Completed first article inspection of new/modified products• Completed internal audits• Managed document control and internal audit systems• Performed color testing using spectrophotometer and color management software• Performed incoming inspection and hourly inspections of in-process production

Madison, Wi

• FDA – regulated, veterinary pharmaceutical manufacturer• Completed final QA approval for records• Maintained archived records• Managed database design and maintenance, document control, and training• Project Manager for MasterControl installation and qualification

Formerly Eragen Biosciences, Madison, Wi

• FDA/ISO – regulated, cGMP medical device manufacturer• Completed final QA approval for records and batch records• Completed lab notebook review• Maintained archived records• Managed database design and maintenance• Performed internal audits for multiple locations• Project Manager for MasterControl installation and qualification• Provided user training for document control and training systems• Served as an active member of the Social Committee, Community Involvement Team, and Safety Committee• System Administrator for EtQ Reliance• System Administrator for MasterControl• System Administrator for Oracle Agile

Madison, Wisconsin Area

• FDA/ISO – regulated, cGMP medical device manufacturer• Completed final QA approval for records and batch records• Completed lab notebook review• Maintained archived records• Managed database design and maintenance• Performed internal audits for multiple locations• Project Manager for MasterControl installation and qualification• Provided user training for document control and training systems• Served as an active member of the Social Committee, Community Involvement Team, and Safety Committee• System Administrator for EtQ Reliance• System Administrator for MasterControl

Madison, Wisconsin Area

• FDA/ISO – regulated, cGMP medical device manufacturer• Completed final QA approval for records and batch records• Completed lab notebook review• Maintained archived records• Managed database design and maintenance• Performed internal audits for multiple locations• Project Manager for MasterControl installation and qualification• Provided user training for document control and training systems• Served as an active member of the Social Committee, Community Involvement Team, and Safety Committee• System Administrator for EtQ Reliance• System Administrator for MasterControl

Cedarburg, Wi

• FDA/ISO – regulated, cGMP medical device manufacturer• Assisted with gage calibration and calibration record maintenance• Assisted with incoming and final product inspections• Assisted with quality assurance and regulatory affairs• Converted document control system from paper-based to network-based• Involved in several FDA inspections, ISO audits, and product recalls• Maintained metrics and quality records• Managed complaint systems and document control• Performed internal audits for multiple locations• Prepared and maintained data analysis reports• Provided safety training to all employees

Cedarburg, Wi

• FDA/ISO – regulated, cGMP medical device manufacturer • Maintained document control system• Assisted with quality assurance and regulatory affairs• Prepared and maintained data analysis reports

Business Management

Management Trainee

An embedded technical diploma in the Business Management Associate Degree.

Process Engineering Technology - Environmental, Health, And Safety Management

Activities and Societies: Society of Manufacturing Engineers, Phi Theta Kappa (Beta Mu Kappa), Student Tutor (Chemistry / Biochemistry /.

Engineering Technologist - Quality Assurance

Activities and Societies: Society of Manufacturing Engineers, Phi Theta Kappa (Beta Mu Kappa), Student Tutor (Chemistry / Biochemistry /.