Dawn Rauch

Senior Quality Consultant

Dawn has more than 20 years of quality systems multidisciplinary experience in the pharmaceutical, medical device, biologics and dietary supplements industries.  Strong design and manufacturing engineering background. Certified Quality Auditor (ASQ); ISO9000 Auditor Certification (BSI).  Performed QMS, due diligence and surveillance audits to ISO13485, CFR’s 111, 211 and 820.

 

EXPERIENCE…
  •  Set-up supplier management program for Swedish device contractor of respiratory healthcare products.  Implemented audit program of critical subcontractors and conducted continuous surveillance audits.  Mentored contractors on quality improvement programs based on audit findings.
    • Located at a critical supplier in Czech Republic for 9 months assisting in the implementation of a compliant (ISO13485) design program for developing a new product portfolio of respiratory products.
  • Consulted on tech transfer of a gas mixing device designed in Austria for use in U.S. hospitals.
  • Provided quality review and sign-off on device design development documents.
  • Performed due diligence audits of potential U.S. device manufacturers.
  • QA responsibility on product transfer team to manufacturing in U.S.
  • Team member on process qualification of new production lines.  Responsible for QA review and sign-off on qualification protocols and reports.
  • Performed quality surveillance audits for pharmaceutical tablet packaging subcontractor and intermediate component processors (specialized intermediate processing pharmaceutical components).
  • In response to a 483, assessed and remediated the Quality Management System of a distributor of drugs, devices and dietary supplements manufactured by sub-contractors.  Critical QMS systems implemented included supplier management program, complaint handling procedures, CAPA, training program, product release procedures, and environmental monitoring (warehouse mapping).
  • Due diligence and QMS audits for CRO services in the U.K.
  • QA/RA representative on biologics technology transfer project team for a new vaccine.  Quality sign-off for batch records, solution prep documents, method transfers, product specifications, cleaning validation, suite and equipment releases.
  • EMTs.  Scope of system included South America, Europe, U.S., Canada, Australia and China.
  • Part of team responsible for qualification of build-out of new manufacturing suites for a large pharmaceutical company; scope of qualifications included compressed air and nitrogen systems, HVAC, dust collector, fluid bed, pan coaters, mixers, mapping of new ovens, packaging line, and extension of the water system.
  • Supported quality initiative for leading medical device manufacturer (Class II and III guide wires) with development of equipment/process validation protocols, pFMEAs, Master Validation Plans, and Master Validation Reports.  Served as quality signature on remediated IQs, OQs, PQs, PPQs, and TMVs.
  • On-site Quality consultant at a medical device supplier (Europe) of Class I (Medical Device Directive, Annex 11) of breathing equipment for an international medical gas provider.  Consulted on development of process equipment qualifications and process validations including process mapping, pFMEAs, IQ/OQs and PQs.  Developed protocol for field upgrades and repairs.
  • Quality lead on qualification of new build-out of R&D suites for a start-up solid dosage company.
    • Qualified v-blenders, fluid beds, pan coaters, granulators, capsule fillers, tablet presses, and ancillary equipment (comils, hardness testers, de-dusters, polishers, etc.).
    • Packaging line qualification included tablet counters/fillers, bottlers, cottoner/dessicant inserters, torquers, induction sealers).
    • Set-up a calibration and preventive maintenance program, including validation of Calibration Manager software.
  • Quality review and sign-off on a Millenium/LIMS installation validation project.  Provided guidance on Part 11 compliance.
  • Conducted environmental mapping study of a new finished pharmaceuticals Warehouse.  Included qualification of the air handling units.
  • Tech transfer of solid dosage products from R&D to manufacturing.
    • Program Management of Engineering responsibilities including equipment purchase, installation, qualification, calibration/PM programs, operating/cleaning SOPs.
    • Wrote batch records/manufacturing protocols for regulatory submission batches.
    • Prepared cleaning verification protocols, calculated product contact areas, assessed and sourced cleaning products, trained on swabbing, prepared reports
POSITIONS HELD…
  • Senior Quality Engineer – BioTeknica, Inc.
  • Associate Director, Technical and Quality Services – Elan Transdermal Technologies
  • Manager, Manufacturing – Motorola
  • Quality Engineer – Bendix/King Avionics
  • Structural Engineer – Rockwell International
EDUCATION…
  •  Architectural Engineering – California Polytechnic State University
CERTIFICATIONS…
  • Certified Quality Auditor (ASQ)
  • ISO9000 Auditor Certification (BSI)