ALAN E. SCHAUB

adt6q3@r.postjobfree.com 805-***-****

SUMMARY

Focused scientist and quality system manager with accomplishments in design control engineering, risk management, product development and regulatory management of innovative pharmaceuticals and medical device products.

Accomplished in the following:

•Critical GMP document management for product protocols, plans and reports.

•Quality assurance and regulatory maintenance towards supporting product development, FDA submissions and EU MDR/IVDR compliance.

•Design control statistical analytics, reliability, and clinical study auditing to assess acceptable class I/II/III medical device conformance, test method validations, dFMEA/pFMEA evaluations, complaint root causes and escalations to effectively correct critical nonconformances.

•Equipment calibration oversight insuring/upgrading cGMP and ISO compliance.

•Corrective action (CAPA’s/SCAR’s) and non-conformance (NC) investigations to foster quality improvements (CIP) and enhance new product performance.

PROFESSIONAL EXPERIENCE

Regulatory Specialist, ICONMA LLC/Abbott Medical, Sylmar, CA 05/2022 – 07/2022

•Active in global regulatory assessments and product release authorization document creations in Windchill for submission under EU MDR.

•Aggressive in EU MDR Summary Technical Document (STED) reviews and submissions related to newly developed introducer/retriever devices.

•Effective in review and editing of change order documentation facilitating ongoing rebranding efforts.

Sr. Quality Scientist, Softpath Systems, LLC/Beckman Coulter, Inc. (Remote) 08/2020 – 12/2021

•Active in class IIa/IIb medical device analytical evaluations, eIFU reviews, Design History File (DHF) management and product development reviews for compliance under EU IVDR.

•Aggressive in data review of gap assessments and associated critical document editing (APR’s, CPR’s PER’s and PMPF’s) which effectively aided device re-registrations under EU IVDR.

•Active in improvements to method characterizations for Beckman Coulter clinical chemistries.

Senior Engineer, Infotree Global / Amgen, Inc., Thousand Oaks, CA 10/2019 – 11/2019

•Improved market releases through participation in cross-functional design control operations (involving design input, output, customer usability, metrics verifications and validations) for new device products.

•Upgraded manufacturing lifecycle operations in Agile based systems through comprehensive re-organization and processing of lifecycle metrics as needed for current CAPA resolutions.

Quality Assurance Specialist, Aerotek, Inc./Caldera Medical, Agoura Hills, CA 12/2018 – 02/2019

•Systematically improved ISO compliance through improved statistical sampling plans and raw material inspections.

•Effectively introduced and managed critical NC/CAPA and root cause improvements following a re-review of calibration operations for manufacturing test equipment.

•Aggressively enhanced process realizations following updates to raw material utilization, re-review of MDR documentation compliance and qualifications for product sterilizations.

Risk Engineer, GPS Staffing / Amgen, Inc., Thousand Oaks, CA 11/2016 – 10/2017

•Productively resolved product compliance / reliability issues through review of device complaint records, current risk severity levels and audit documentation to facilitate needed corrective escalations.

•Effective in managing and resolving audit CAPA investigations associated with current risk assessments through aggressive review and establishment of risk level rationales.

•Aggressive in post market surveillance monitoring through effective reviews and analysis of complaint records.

Product Surveillance Manager, Aerotek / Medtronic, Inc., Northridge, CA 06/2015 – 08/2016

•Developed corrective escalations through comprehensive cross-functional review of customer complaints and associated failure analysis evaluations (DFMEA/PFMEA) for CGM device systems.

•Improved product compliance with critical investigation timelines by facilitating CAPA/NC remediations for class II / III devices with associated data mining of product complaints in SAP/Trackwise systems.

•Actively executed post-market surveillance (PMSR) and reliability evaluations by authoring technical summary reports which effectively identified critical product issues and promoted compliance escalations.

Stability Quality Specialist, RD Partners / Amgen, Inc., Thousand Oaks, CA 03/2011 – 01/2014

•Aggressive in coordinating QA reviewer deliverables for stability data operations including specialized HPLC data formats required for CMC and pre-BLA FDA submissions.

•Productive in stability data integrity evaluations, CTD framework and trending observations throughout small molecule PPQ, drug substance and drug product development / manufacturing.

Validation Engineer, Siemens Healthcare, Los Angeles, CA 08/2004 – 03/2010

•Successfully provided quality/regulatory support for 21CFR 210, 211, 806, 820, ISO 13485 compliance and FDA 510K/PMA submissions through efficient oversight of design control processes.

•Efficient in IVD project deliverables through use of effective PQ,OQ processing, CAPA reviews, DHF updates and oversight of IFU updates in a cross functional matrix operation.

•Provided design control monitoring of ELISA validation and manufacturing process control data as well as critical GMP/GLP oversight for supplier qualifications, validation expectations and audit readiness.

•Innovative in facilitating effective process improvements to promote optimizations including related statistical quality metrics through real time data transfer from LIMS systems, processing, and review.

•Active in DFMEA/PFMEA operations through effective use of risk management tools and root cause processes to enhance new or improved product launch.

EDUCATION

M.S. Brigham Young University

Major: Microbiology/Biochemistry

B.S. Brigham Young University

Major: Microbiology/Chemistry

SKILLS

•Computer – Microsoft 365 software (including Excel statistical analysis formats and add-ons); Waters Empower HPLC software; MS Project; Trackwise/SharePoint software; IRPC/Bioconnect complaint management systems; VEEVA(CDOCS)/EDMS/Windchill document systems; Resolver risk management software.

•Professional Development – Time management/multitasking and six sigma training; ANSI sampling; proficiency in quality system regulations (21CFR 11, 210, 211, 820, ISO13485:2016, ISO14971); IEC 60601, ELISA/Bioassay formats, CTD structures, continuous improvement (CIP) formats, MDR and IVDR requirements; root cause and FMEA analysis formats (Fishbone, and Kepner-Tregoe); ANSI / ASQ Z1.4 sampling; Minitab training.

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