Qa Officer Resume Example

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Jessica Claire
, , 100 Montgomery St. 10th Floor (555) 432-1000,
Professional Summary

Experienced professional knowledgeable about registrations, audits, inspections and industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills.

  • ISO 17025
  • HAACP Certified
  • Six Sigma Black Belt
  • Staff training and development
  • ISO 9000 standards
  • Root Cause Analysis
  • Continuous Improvement
  • Good Laboratory Practices (GLP)
  • Good Manufacturing Practices (GMP)
  • IATF 16949
Work History
06/2019 to Current QA Officer Principia Biopharma Inc. | San Antonio, TX,
  • Reviewed project planning documents (technical protocols, test plans, software development plans, systems engineering plans, manufacturing plans, etc.) for compliance with applicable stated requirements.
  • Scheduled and performed critical phase inspections to ensure compliance with stated requirements.
  • Audited records and reports for compliance to stated requirements.
  • Planned and coordinated on-site audits from external sources.
  • Guided project to GLP compliance to 40 CFR Part 160 which grew business line.
  • Transitioned R&D project to production utilizing FMEA, Control Plans, APQP.
  • Evaluated quality problems and performed root cause analysis to identify and resolve issues.
  • Liaised with project manager to organize and perform annual quality standard training for new and existing staff.
  • Improved quality processes for increased efficiency and effectiveness.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
03/2018 to 05/2019 QA Manager Letsgetchecked | Atlanta, GA,
  • Planned, developed, & maintained Quality Systems ensuring conformance to customer, internal business, and regulatory requirements.
  • Ensured processes and products met defined levels of Quality acceptability.
  • Ensured appropriate use and implementation of Quality tools & techniques (APQP, PPAP, FMEA, Control Plans, SPC, DMAIC, Lean).
  • Trained, coached, developed and mentored Plant Quality team members.
  • Facilitated and oversaw robust root cause analysis and data driven problem solving methodologies reducing customer complaints, scrap, and inspection costs reducing HFI (Hold for Inspection) from 1.3 M to 50 K.
  • Steered engineering, manufacturing and corporate accounting to verify adherence to quality standards.
03/2014 to 03/2018 QA Manager Letsgetchecked | Philadelphia, PA,
  • Established strategies to ensure compliance and risk mitigation in association with ISO 9001 and TS 16949.
  • Transitioned QMS from ISO/TS 16949:2009 to IATF16949:2015.
  • Ensured compliance with Design and Development via internal Product Handoff (stage definition and deployment of product quality assurance strategies).
  • Created documentation including Quality Manual, SOPs, Verifications and Validations, Specifications, PFMEA, CP, and PPAP.
08/2011 to 02/2014 Document Coordinator, Team Lead Abbot Laboratories | City, STATE,
  • Verified data integrity in GMP compliant environment by documenting nonconforming product to sustain highest level of quality for batch release
Expected in Bachelor of Science | Aerospace Engineering Technology Kent State University, Kent, OH GPA:

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Resume Overview

School Attended
  • Kent State University
Job Titles Held:
  • QA Officer
  • QA Manager
  • QA Manager
  • Document Coordinator, Team Lead
  • Bachelor of Science

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