Teva Rothwell

Sr. Quality Scientist

Teva is a well-rounded professional with over 28 years of experience in the biological research, clinical diagnostics, and pharmaceutical industries. He has expertise in FDA- and ISO-compliantmanufacturing, research and development, quality assurance, quality control, and regulatory affairs. Teva is detail-oriented, personable and has a focused business style with effective problem solving abilities. He possesses outstanding written and verbal communication skills and is committed to the highest levels of excellence, integrity, and client satisfaction.

EXPERIENCE

Consultant

Globally, Teva has provided a broad range of consulting and compliance services for numerous medical device andpharmaceutical companies including organizations under consent decree and warning letter.

  • Quality system audits (QSR, ISO, GxP, ICH)
  • Quality system remediation
  • CAPA
  • Design Control
  • Complaint/MDR
  • Regulatory submission preparation
  • Risk analysis
  • FDA inspection readiness
  • ¬†Technical data review
  • Process development
  • Test method validation
  • Vendor qualification
  • Six Sigma DMAIC methodology
  • Project management
  • Procedure writing/review

Vice President, Manufacturing & QA/QC, RNAture, Inc. (HITACHI Chemical Research Center, Inc.)

Established and managed Manufacturing, Quality Assurance, Quality Control, Packaging and Labeling, and Shipping and Receiving departments. Transferred novel technology from R&D into the manufacturing environment. Responsibilities included process development and optimization, robotic automation, facility build-out, equipment selection and procurement, vendor qualification, protocol validation, packaging and labeling, troubleshooting, and all manufacturing and quality documentation.

Director of Regulatory Affairs / Quality Assurance, International Enzymes, Inc., San Marcos, CA

Established Regulatory Affairs/Quality Assurance department.Generated all 510(k) submissions. Designed and founded company quality system and document control system. Advised R&D and Manufacturing regarding experimental designs to satisfy 510(k) submission requirements.Authored numerous procedures to satisfy cGMP requirements.Conducted internal and external audits.Provided company-wide training to educate all employees regarding ISO 9001 requirements.Produced ISO 9001 General Awareness Training Manual to aid in understanding and practical application. Wrote all labeling (including package inserts) for new products.

Regulatory Affairs / Research Scientist, Bio-Rad Laboratories, ECS Division, Anaheim, CA

Established Regulatory Affairs department at ECS Division. Generated all 510(k) submissions and conducted all corresponding communication with FDA officials. Ensured company compliance with cGMPs and recommended appropriate actions to correct deficiencies. Conducted internal and external audits. Coordinated and implemented several field corrective actions. Authored procedures describing all regulatory functions.Company contact for FDA, DEA, DSMA, CDC, and other regulatory agencies. Actively participated to achieve company goal of ISO 9001 registration (member of Management Steering Committee, company escort during audits, reviewed all major procedures, provided guidance and recommendations to executive management). Developed a stable liquid therapeutic drug monitoring control including design, feasibility, scale-up, process improvement, documentation, and 510(k) submission.

Manufacturing Engineer, Hycor Biomedical Inc., Garden Grove, CA

Transferred three major product lines from R&D to Manufacturing including technology transfer, pilot plant scale-up, cGMP-compliant manufacturing and quality control documentation, laboratory design and set-up, cost accounting, and interdepartmental relations. Developed diagnostic ELISAs to measure apolipoproteins A-I and B in human plasma utilizing monoclonal antibodies concurrently developed.

Research Chemist, Radioassay Systems Laboratories, Inc., Carson, CA

Developed, produced, and monitored performance and quality of several radioimmunoassays. Performed internal audits to satisfy cGMP requirements.

EDUCATION:

Bachelor of Science Degree in Biological Sciences, UC Irvine, Irvine, CA

(Curriculum included graduate-level courses in molecular biological techniques)

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