Air Force Medical Device
Resume:
Michaela Wehr
***** ******** **, ****** ******, CA 92557
*****.****@*****.***
PROFESSIONAL PROFILE
Quality and regulatory affairs experienced individual with project management, risk management, quality control, regulatory, and environmental regulation expertise. Organized and professional leader within regulatory fields. Monitors various systems under global regulatory bodies including CalEPA, EPA, NEPA/CEQA, DOT, OSHA, IATA, IMDG, and FDA. Manages review processes using Risk Management (ISO 14971:2007), Environmental Management (ISO 14001:2015), Medical Device Quality System regulations (ISO 13485:2016), and Device Biocompatibility (ISO 10993:2018). Manages work environments compliant with 40 CFR 239-282 (RCRA), 21 CFR 210-328 (pharmaceuticals), and 21 CFR 803-860 (Medical Device Requirements). Project management, supply chain management, and hazardous review for logistical distribution for private label, self-manufactured, and 3PL products.
WORK EXPERIENCE
United States Air Force Reserve Command, Moreno Valley CA
Environmental Management Systems Manager 09.2018 – present
Collaborate on EMS for entire March Air Reserve Base on Air Force servers. Initiated quality systems for air quality, water quality, hazardous material management and waste, and natural resources. Cradle-to-grave monitoring of hazardous materials and hazardous waste.
Planning, establishing, organizing, and implementing environmental management system and training resources for base contractors and employees (roughly 4100 personnel).
Cardinal Health, Dublin OH
Senior Quality and Regulatory Affairs Specialist 01.2016 – 09.2018
Multi-task project management for private label, self-manufactured, and 3PL medical devices, supplies, and pharmaceuticals. Analyze, interpret, and evaluate statistical data metric for quality team.
Autonomous judgement for review of material storage, transport, distribution, and licensing (internationally manufacture or source 2.5 billion supplies annually).
Boehringer Ingelheim – Roxane Laboratories Inc., Columbus OH
Senior Documentation Specialist 03.2014 – 01.2016
Organize and present statistical analysis of data for FDA and/or DEA filing reports. Data compiled and presented in deadline-driven annual stability reports, new drug applications, and abbreviated new drug applications.
Create technical (T-spec), regulatory (R-spec), and packaging (P-spec) specifications for all products within BIRI’s portfolio (19 brand-name drugs, 126 generic drugs), utilizing electronic Trackwise system.
Ohio State University Medical Center, Columbus OH
Clinical Research Data Coordinator 04.2012 – 03.2014
Document, aliquot, process, accession, and distribute research tissue samples for Alliance/CALGB (Cancer and Leukemia Group B) cancer clinical trials. Advanced research and statistical methods including data collection and analysis.
The Alliance Biorepository at Ohio State University (ABOSU) currently has over 500,000 tissue and fluid bio-specimens banked, processes over 20,000 specimens, and distributes nearly 10,000 samples per year.
EDUCATION
Kettering College of Medical Arts, Kettering OH
Bachelor’s of Science (BS) Human Biology 08.2007 – 04.2010
SKILLS
Certified Typing: 75 WPM (words per minute / 22500 KPH (keystrokes per hour)
Six Sigma Yellow Belt
CBEST (California Substitute Teaching License)
Eligible certifications: SS Green Belt, PMP, PE, CQA, CQE
Proficient in Microsoft Office (Word, PowerPoint, Outlook, Access, Excel, Visio), SQL queries, Minitab, SAS, Oracle (Agile, Peoplesoft), SAP (Logistics, Quality Management, Supply Chain Management)
Contact this candidate