Andrea Carlson

Andrea Carlson 840 85th Lane NW Coon Rapids, MN 55433 - cell-Objective: Looking for a challenging position in a fast paced, growth oriented environment that can utilize my knowledge, skills and experience to support the organizations overall mission. Experience: Torax Medical, Inc., Shoreview, MN - June 2014 – present Quality & Documentation Specialist • Conduct Document Control Training • Conduct new hire and annual QS/GDP training • Execute Document Control system and provide expertise in its implementation and maintenance • Ensure DCO’s are complete and accurate with a processing goal of 1 day or less • DHR review • Monthly field inventory traceability assessment • Maintain Document Control software • Lead and execute calibration requirements • Maintain all off-site record storage • Internal/External auditor • Lead pest control activities • Quarterly cleanroom monitoring coordination and review • Lead integration specialist for multiple workstreams • Primary “go to” for all questions • Manage 1 full time employee and multiple contract employees • Other duties as assigned Smiths Medical, Arden Hills, MN - April 2013 – June 2014 Document Control Supervisor • Manage full time staff of 5 full time employees • Conduct staff meetings • Conduct mid-term and annual review for staff • Conduct new hire orientation related to the Document Control function • Coordinate with staffing agencies as needed for temporary personnel • Facilitate cross departmental meetings • Working knowledge of QSR Regulations / cGMP • Working knowledge of ISO 13485, 17025, 9000 standards • Train personnel on procedures, software programs, QSR Regulations, ISO Standards • Track training on all employees, updating training as required • Track and process all controlled and uncontrolled documentation for organization via change control process • Maintain and update document control system • Maintain and update all change control procedures as required PrimeWest Health, Alexandria, MN - June 2007 – April 2013 Claims Processing Manager • Manage full time staff of 17 full time claims examiners and COB personnel • Ensure claims are paid in timely manner according to state and federal guidelines • Conduct staff meetings • Conduct mid-term and annual review for staff • Review policies/procedures for department • Oversee development of workflows • Test workflows • Train personnel in writing workflows • • • • • • • • • Train personnel on procedures, software programs Coordinate with staffing agencies as needed for temporary personnel Interviewed, hired and released temporary personnel Assist call center in taking provider calls as needed Facilitate cross departmental meetings Assist in system testing as needed for upgrades Knowledge of CMS and DHS guidelines and reimbursement methodologies Compliant with all HIPAA regulations Travel as required AbbeyMoor Medical, Inc., Parkers Prairie, MN - May 2004 – June 2007 Quality Technician Document Control Coordinator Internal Auditor • Maintain and update document control system • Maintain and update all change control procedures as required • Track and process all controlled and uncontrolled documentation for organization via change control process • Coordinate software system review for future implementation • Coordinate Internal/External Auditor Schedules on annual basis • Conduct Internal Audits and External Audits • Coordinate with Belgium distributor for the storage of company product • Develop procedures for use at distribution center • Develop training tracking spreadsheet for all employees • Track training on all employees, updating training as required • Update departmental processes and other department processes as needed • Train personnel on procedures, software programs, QSR Regulations, ISO Standards • Assist with Management Review Meetings including taking notes, distributing notes, notifying and tracking action items to assigned individuals • Assist IT department when needed • Additional duties as assigned • Active participant of FDA, ISO Audits • Member of the Safety committee • Working knowledge of QSR Regulations /cGMP • Working knowledge of ISO 13485, 17025, 9000 standards Biotest Laboratories, Inc., Coon Rapids, MN - March 2000-April 2004 Document Control Internal Auditor Biomedical Focus Committee Member • Update procedures into Information Mapping Format • Coordinate technology transfer of 150+ documents from an external company into the Biotest Labs system • Perform internal audits • Active participant of FDA, ISO and numerous external client audits • Assist QA in closing of Corrective and Preventive Actions (CAPA) • Assist QA in all Quality Planning Meetings including taking notes, distributing notes, notifying and tracking action items to assigned individuals • Attended numerous off-site seminars (Process Mapping, CAPA’s, Internal Auditing, ISO) • Updated departmental manuals with corresponding procedures/forms • Implemented new security system • Coordinated all telephone matters (adds, moves or changes within the system) • Working knowledge of QSR Regulations / cGMP • Working knowledge of ISO 17025, ISO 13485, ISO 9002 Seal Guard Systems, Inc., Arden Hills, MN - September 1998-March 2000 Assistant Administrative Manager HR Director • Answered and directed 10+ incoming lines • Typed correspondence to the BBB and the Department of Commerce • Entered new customer information into Quickbooks and Market Sharpe • Typed insurance information for customer’s insurance companies • Pulled permits needed for work to be done at specified properties • Calculated and tracked all Sales and Telemarketing commission sheets in Excel and Quickbooks • Issued new hire paperwork and covered information needed for the new hire to welcome them to the company • Managed medical and dental benefits • Developed a tracking system of new hires and past employees regarding eligibility dates for benefits and vacation • Created departmental forms as needed • Prepared proposals for the commercial sales department • Completed additional tasks throughout company when needed Award Staffing Services, Edina, MN - August 1995-June 1998 Receptionist Interviewer Clerical Staffing Manager • Answered and directed 20+ incoming lines • Greeted clients and applicants • Issued applications, completed I-9 documents, interviewed applicants • Entered applicant information into Matchmaker database • Prepared proposals for account representatives • Designed ads for weekly papers • Managed ongoing client relationships • Negotiated employer fees and bill rates according to Awards policies and agreements • Assessed appropriate salary ranges in conjunction with qualifications set by the client • Recruited candidates through phone screening, interviews and testing • Provided procedural training for new candidates Education: Graduate of Coon Rapids High School with an emphasis in business courses Skills: Excellent customer service skills, work well in a fast paced environment, type 65+ wpm accurately, Microsoft Office 2010, Office 365 (including: Outlook, Lync, PowerPoint, Visio, Access, Excel and Word) Adobe Acrobat Professional, Compliance 360, Confluence, JIRA, Oracle, Amisys (internal claims system), MACESS, NEXUS (internal documentation system), CSA (internal customer service application), and excellent data entry. Certifications/Achievements: • Quality Management System Lead Auditor (ISO 9001:2008) with Emphasis on Medical Devices (ISO 13485:2003) September-2015 • American Heart Association - HeartSaver First Aid, CPR, AED Certified – January 2018, Renewal January 2020 • FDA Quality System Inspectional Techniques – January 2001 • ISO 9000:2000 Project Management, Documentation and Corrective Action – December 2001 • ISO 9001:2000 Documentation - November 2001 • CAPA and Root Cause Analysis – August 2001 • Internal Quality Auditor Training – ISO- – August 2001 • Mistake-Free Grammar and Proofreading – December 2000