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Regulatory Affairs Specialist resume example with 8+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
:
Summary

Quality and Management System Professional with more than 8 years of experience in both public and private sector organizations.

With experience in: Regulatory Affairs, Regulatory Standards (ICH, NSF, ISO, GMP, Medical Laboratory Practices, SO/ IEC 17025:2017 Standards, GYS 170 Standards), Training (ISO 45000:2018 Certified Trainer), Safety Management, Quality Management, Quality Assurance??, Supervision, Data Analysis, Procedural Writing, Quality Management Systems Consulting / Development, Auditing (Internal, External, Laboratory, Food Processing), Medical and Testing Laboratory Assessment, Developing KPIs, Statistical Process Control, Food Safety Management Systems and HACCP (Hazard Analysis Critical Control Point) programs.

Skills
  • Quality Audits
  • Management System Audits
  • Risk Management
  • Quality Assurance
  • Quality Control
  • Inspections
Education and Training
, Expected in 01/2018 ISO 45000 : - GPA :
, Expected in 01/2018 Certified Trainer - ISO 9001:2015 Lead Auditor, - ISO 9001 IRCA Lead Auditor - Medical and Testing Laboratory Assessor - Statistical Process Control, ISO 22000 : - GPA :
, Expected in 01/2017 - Food Safety Management Systems - ISO 15189 Standard - Good Medical Laboratory Practices - SO/ IEC 17025 : - GPA : Standards - GYS 170 Standard
, Expected in 01/2017 SO/ IEC 17025 : - GPA :
University of Guyana , Expected in 11/2014 Bachelor of Science : Biology - GPA :
, Expected in Diploma : Quality Management - GPA :
, Expected in Good Laboratory Services - ISO 22000: 2018 Food Safety Management Systems - ISO/IEC 17020:2012 : - GPA : Conformity Assessment — Requirements for the operation of various types of bodies performing inspection
, Expected in GYS 170 Standards), Training (ISO 45001:2018 Certified Trainer), Safety Management, Quality Management, Quality Assurance, Supervision, Data Analysis, Procedural Writing, Quality Management Systems Consulting / Development, Auditing (Internal, External, Laboratory, Food Processing), Medical and Testing Laboratory Assessment, Developing KPIs, Statistical Process Control, Food Safety Management Systems and HACCP (Hazard Analysis Critical Control Point) programs. (See Education / : - GPA : Certifications below for additional details.
Certifications

3. Facilitating training on Quality Control and Management System Standards 5. Auditing of Products for the purpose Certification 6. Auditing of Laboratory and Organization for the purpose of Certification.

Experience
Agilent Technologies, Inc. - Regulatory Affairs Specialist
, , 06/2020 - Current
  • Conducting Internal Audits
  • Creating, reviewing and approving Standard Operating Procedures (SOPs)
  • Monitoring and maintaining Organic, Halal and GMP Certification for the organization
  • Monitoring and maintaining regulatory compliance for the organization
  • Quality Supplier Management
  • Serving on audit response team
  • Processing Change Control, Deviations, Customer Complaints.
  • Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics.
Toxic Control Board - Lead Quality Auditor and Consultant
City, , 01/2017 - Current
  • Investigated and identified quality issues to uncover root causes and explore potential corrective actions.
  • Inspected production areas regularly to identify and process violations impacting final quality results.
  • Conducted audits for clients to assess products for compliance with international standards.
  • Highlighted compliance issues for management team.
  • Built relationships with customers to facilitate communication.
  • Made travel plans and conducted assessments at clients' facilities.
  • Identified internal and external issues within the organizations in accordance with the ISO 9001:2015 Standard
  • Mapped all core and support processes within the organizations
  • Conducted initial Gap Analysis, to determining existing gaps
  • Developed project plan
  • Trained select employees on ISO 9001:2015 Standard Requirements
  • Developed the organization’s Quality Policy
  • Drafted overall system procedures and Standard Operating Procedures (SOPs)
  • Established KPIs
  • Developed systems to control externally provided products and services
  • Trained key employees on conducting internal Quality Audits to establish a Continuous
  • Improvements
  • Used consistent and fair assessment procedures to achieve optimal audit results.
Guyana National Bureau Of Standards - Consultant /Quality and Management System Auditor
, , 05/2017 - 03/2020
  • Auditing of Quality and Management Systems
  • Establishing Quality Control and Management Systems ISO 9001:2015
  • Identified quality problems and recommended solutions.
  • Analyzed issues and recommended corrective actions to improve final results.
  • Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
Edward B Beharry And Co Ltd - Quality Control Inspector/Officer
, , 11/2014 - 05/2017
  • 1
  • Laboratory Analysis of Final Products and Raw Materials 2
  • Inspection of Raw Material for Production 3
  • Product and plant inspection 4
  • Inspecting Finish product 5
  • Inspecting Color, Moisture and Particle size of product 6
  • Inspection of product on production line 7
  • Product Development 8
  • Auditing of the Quality Management Systems 9
  • Pest control inspection 10
  • Inspection of transport vehicle before and after offloading
Activities and Honors
Member of the American Society for Testing and Materials (ASTM) Technical Committee - ISO Auditors

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Resume Overview

School Attended

  • University of Guyana

Job Titles Held:

  • Regulatory Affairs Specialist
  • Lead Quality Auditor and Consultant
  • Consultant /Quality and Management System Auditor
  • Quality Control Inspector/Officer

Degrees

  • ISO 45000
  • Certified Trainer - ISO 9001:2015 Lead Auditor, - ISO 9001 IRCA Lead Auditor - Medical and Testing Laboratory Assessor - Statistical Process Control, ISO 22000
  • - Food Safety Management Systems - ISO 15189 Standard - Good Medical Laboratory Practices - SO/ IEC 17025
  • SO/ IEC 17025
  • Bachelor of Science
  • Diploma
  • Good Laboratory Services - ISO 22000: 2018 Food Safety Management Systems - ISO/IEC 17020:2012
  • GYS 170 Standards), Training (ISO 45001:2018 Certified Trainer), Safety Management, Quality Management, Quality Assurance, Supervision, Data Analysis, Procedural Writing, Quality Management Systems Consulting / Development, Auditing (Internal, External, Laboratory, Food Processing), Medical and Testing Laboratory Assessment, Developing KPIs, Statistical Process Control, Food Safety Management Systems and HACCP (Hazard Analysis Critical Control Point) programs. (See Education /

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