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senior qa specialist resume example with 8+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Summary

PROFILE SUMMARY Quality Assurance professional with 8+ years of QA/QC Pharmaceutical industry experience. Committed to quality, compliance and continuous improvement to embrace the company’s vision and industry best practices.

Skills
  • Quality System Implementation
  • Deviations
  • Continuous Improvement
  • Inspection Readiness
  • External Quality
Work History
Senior QA Specialist, 05/2020 - Current
Apex Systems Erlanger, KY,
  • Participated in Veeva QMS implementation activities including UAT testing and implementation protocol execution
  • Performed site wide user training on Veeva QMS system
  • Deviation and CAPA Veeva QMS system owner
  • Performs Root Cause Analysis on Major and Critical deviations originating from various departments including the Microbiology and QC Laboratories, Quality Systems, Manufacturing and Facilities
  • Performs quality review and approval of investigations conducted by the owning departments
  • Compile investigation and CAPA metrics including closure rates based on criticality, on time closure, extension percentage, rate of reoccurrence and effectiveness
  • Influence CAPA decisions and process improvements, review and approve CAPA Implementation Summaries and Effectiveness Checks
  • Supported audit activities as deviations and CAPA SME
  • Quality member participating in Change Control Review Board meetings, reviewing change control concept and implementation activities from a compliance standpoint
  • Key Accomplishments
  • Performed a complete review of the Data Integrity Process at the site and implemented a more robust process
  • Developed an Investigator Training Program for structured training and assessment of new investigators
  • Developed a human error deviation remediation program for a process driven method of handling human error root causes across the site.
Quality Assurance Investigator, 11/2018 - 06/2020
The Resource Center Wellsville, NY,
  • Performed investigation review of minor, major and critical investigations originating from the Microbiology and QC Laboratory, Quality Systems and Manufacturing
  • Provided support to process owners by leading cross-functional brainstorming sessions, performing root cause analysis (five whys, cause and effect, etc.), writing robust investigation reports and identifying and influencing appropriate CAPA
  • Reviewed and approved investigation reports generated at outside contract testing laboratories prior to batch disposition
  • Investigations SME during regulatory audits and addressing audit observations
  • Tracked individual and overall department metrics and KPIs and submitted monthly departmental metrics to senior management including average investigation closure rates, investigation trend by department and root cause type, and status of open CAPAs
  • Weekly team meeting presentation to leadership team on the status of these items and ensuring that meeting minutes were distributed to the necessary individuals
  • Continuously involved in operational excellence projects and was identified as a mentor for core problem solving participants
  • This was geared to identify the root cause of the highest operational wastes and to identify cost effective solutions to improve processes
  • Managed the CAPA workflow from initiation to effectiveness check
  • Key Accomplishments
  • Collaborated with key decision makers on value stream analysis of the investigation process to reduce waste in the process, update and improve departmental procedures, drive investigations to closure and improve investigations metrics
  • Was selected as the site CAPA coordinator to review proposed corrections and actions stemming from non-conformances and to decide whether they are suitable or should be escalated to the management review board
  • Tracked the CAPA process from initiation to closure
  • Participated in “train the trainer” course was appointed as the SME trainer for investigating non- conformances and developed new training curriculum for investigators.
Senior Quality Assurance Associate, 10/2015 - 11/2018
Abbott Laboratories Westford, MA,
  • Managed deviations, CAPAs and change controls from the laboratory
  • Authored SOPs, SOP updates, work instructions and Validation Protocols
  • Quality oversight of equipment
  • Ensured facility FDA registrations, DEA registration and DEP certification were maintained
  • Reviewed and approved sponsor quality agreements
  • Coordinated with external partners and regulatory agencies for quality audits and ensured timely responses to these audit activities
  • Performed new and ongoing employee training on cGMP, GLP and internal SOPs
  • Developed performance goals and tracked key performance metrics for direct reports
Laboratory Analyst, 12/2012 - 12/2014
Chevron Covington, LA,
  • Performed analyses on pharmaceutical, cosmetic and nutraceutical samples using techniques including HPLC, GC and UV as per USP methods or other internally developed methods
  • Performed various wet chemistry methods for various dosage forms
  • Completed logbooks and all other GMP records as per company SOPs and Good Documentation Practices.
Education
Master of Science: Pharmaceutical Chemistry, Expected in
-
Fairleigh Dickinson University - ,
GPA:
Status -
Bachelor of Science: Biochemistry, Expected in
-
State University of New York - ,
GPA:
Status -

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Resume Overview

School Attended

  • Fairleigh Dickinson University
  • State University of New York

Job Titles Held:

  • Senior QA Specialist
  • Quality Assurance Investigator
  • Senior Quality Assurance Associate
  • Laboratory Analyst

Degrees

  • Master of Science
  • Bachelor of Science

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