ALAN E. SCHAUB
Focused scientist and quality system manager with accomplishments in quality engineering, risk management, product development and project management of innovative pharmaceuticals and medical device products.
Skilled in the following areas of expertise:
Risk management oversight including analysis, plans and project updates
Project management for validation operations, facilitating launch of new medical devices
Design control operations and EU MDR regulatory oversight supporting new product marketing as well as FDA 510K, PMA and CE Mark submissions for biomarker products.
Product complaint reviews to assess root causes, establish new product controls and initiate escalations for effective and timely resolution of product issues.
Equipment management to insure cGMP and ISO regulatory compliance.
Corrective action (CAPA’s/SCAR’s) and non-conformance (NC) investigations to upgrade/enhance new product performance and correct potential product issues.
Senior Engineer, Infotree Global / Amgen, Inc., Thousand Oaks, CA 10/2019 – 11/2019
Aggressive training and oversight in design control operations (design input, output, verifications, validations) for effective market release and EU MDR compliance of combination device products.
Effective in reviewing and approving updates to packaging specifications and related documentation for new project lifecycle (PLM) formats using SharePoint, Agile and CDOCS software.
Active in devising corrective measures to FDA observations using root cause analysis formats.
QA Calibrations Specialist, Aerotek, Inc / Caldera Medical, Agoura Hills, CA 12/2018 – 08/2019
Systematically improved quality inspections, specification reviews, sampling techniques and regulatory compliance through improved oversight in monitoring needed equipment calibrations.
Effective in organizing/managing NC/CAPA investigations and updating needed GMP technical documentation following review of calibration practices in device manufacturing.
Productive in training procedures for MDR reviews and submissions.
Aggressive in improving sampling formats for cleanroom monitoring to improve business operations.
Risk Engineer, GPS Staffing / Amgen, Inc., Thousand Oaks, CA 11/2016 – 10/2017
Productively addressed product complaint issues through thorough review of complaint record trends, product redesigns and risk analysis processes using effective risk management process operations.
Effective in managing CAPA investigations involving risk assessment plans/ updates with project core team members through an organized framework of needed deliverables in the SharePoint system.
Active in reviewing and correcting FDA audit observations by incorporating upgrades to risk assessments in risk analysis matrices.
Device Surveillance Analyst, Aerotek / Medtronic, Inc., Northridge, CA. 06/2015 – 08/2016
Advised on potential device corrective escalations through review of customer complaint records and associated failure analysis investigations (DFMEA/PFMEA).
Improved CAPA/NC workflow through facilitating critical investigational closures associated with product complaints and in accordance with resolution timelines.
Actively supported improvements in device design controls and complaint surveillance through authoring of technical reports identifying quality compliance issues, risk evaluations and resolutions.
QA Stability Specialist, RD Partners / Amgen, Inc., Thousand Oaks, CA. 03/2011 – 01/2014
Aggressive in coordinating essential deliverables for stability technical documentation for pre-BLA FDA submissions in accordance with regulatory filing deadlines.
Thorough in improving efficiency for tracking department operations by effective transcribing, revising and approving critical stability documents in workflow systems (EPIC/ EDMQ/ CCMS).
Productive in critical process data monitoring/comparative verifications throughout DS/DP drug development and manufacturing.
Validation Project Engineer, Siemens Healthcare, Los Angeles, CA. 08/2004 – 03/2010
Effectively provided needed support and compliance with 21CFR 11, 210, 211, 820 and ISO 13485 regulations through efficient management of current verification / validation processes.
Efficient in use of critical path management tools to drive validation improvements, promote device transfer and launch 8 new medical device products through effective data analysis and coordination with product development, marketing and manufacturing operations groups.
Provided continual GMP compliance oversight through periodic reviews and compliance checks for critical design control parameters including validation protocols/reports, needed change controls and deviations, finished product technical reviews and raw material specifications.
Innovative in providing solutions to critical validation engineering issues by establishing real time data monitoring and transfer into unique analytical systems.
Aggressive in improving device manufacturing through reviews of CAPA investigations for improved manufacturing control.
Productive in establishing resolutions in product design changes with project core team members to maintain timely deliverables to market for new innovative IVD projects.
Active in leading risk management DFMEA operations through effective use of risk engineering and root cause processes including risk plans, updates to risk files and risk reports.
M.S. Brigham Young University
B.S. Brigham Young University
Computer – Microsoft Office software (including Word/MS Project /Excel and Excel add-ons/VLOOKUP/Pivot tables); Minitab statistical software; Analyze it software; MS Project; Trackwise and SharePoint software; SAP/ERP software; VEEVA(CDOCS)/CCMS/Agile PLM/EDM management systems.
Professional Development – Time management/multitasking training; ANSI sampling; proficiency in quality system regulations (21CFR 11, 210, 211, 803, 820; ISO9001, EN/ISO 60601, 62304; ISO13485:2016, ISO14971), fishbone evaluations, lean/six sigma DMAIC methodologies; Resolver risk management; MDR oversight; project management tools (pert/gnat charts, logic networks, WBS).