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Specialist, GxP Compliance Auditor Resume Example

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SPECIALIST, GXP COMPLIANCE AUDITOR
Professional Overview
To obtain a position that will enable me to apply my knowledge and experience in quality compliance.
Experience
Specialist, GxP Compliance Auditor 11/2013 to Current Emergent BioSolutions Lansing, MI
  • Develops and maintains internal audit schedule for upcoming year.
  • Writes and distributes audit plans, checklists and reports.
  • Plans, schedules and conducts internal quality systems audits.
  • Prepares audit reports and communicates audit results to audited areas.
  • Provides support in determining root cause analysis and corrective and preventive action.
  • Works with area management on audit responses and corrective actions.
  • Verifies corrective action effectiveness according to regulatory expectation.
  • Collects tracking and trending information.
  • Reports metrics to Manage Review program.
  • Authors, revises/reviews Standard Operating Procedures (SOPs).
  • Participates in Regulatory Inspections.
  • Supports Regulatory Inspection responses.
Senior Research Compliance Specialist 05/2007 to 11/2013 Cincinnati Children's Hospital Medical Center Cincinnati, OH
  • Reviewed and approved Master Production Records, SOPs, Specifications, Validation Protocols, Stability Protocols, Change Control, etc.
  • Managed document control of SOPs, validation documentation, Production Records and other pertinent records.
  • Performed final disposition of finished products and materials.
  • Reviewed and approved executed batch production records and supporting documents such as environmental monitoring, cleaning records, labeling documentation and product storage and distribution records.
  • Reviewed and approved deviations and other associated documents such as CAPAs and Quality Investigation Reports.
  • Trended deviations and reviewed trends with facility management for Quality Improvement.
  • Managed external audits.
  • Performed routine internal audits to ensure compliance with Good Manufacturing Practices (GMP) for sterile drug products produced by aseptic processing.
  • Provided oversight of training database and training requirements.
  • Provided GMP training to facility staff.
  • Provided quality oversight of Investigational Pharmacy activities performed in GMP facility.
  • Provided quality oversight of cellular therapy processing for Good Tissue Practice compliance.
  • Performed record review of study documents for Good Laboratory Practices.
02/2006 to 05/2007 Kendle International Cincinnati, OH
Clinical Quality Assurance Auditor I 05/2004 to 10/2005
Clinical Quality Assurance Auditor 02/2006 to 10/2006
  • Hosted sponsor audits at Kendle.
  • Responded to and resolve issues related to sponsor audits.
  • Conducted investigator site audits, regional office audits, vendor audits and internal systems audits to ensure contracted clinical trials are in compliance with protocol, SOPs, Project Plans, international requirements for Good Clinical Practices (GCP) i.e.
  • ICH-GCP.
  • Wrote, reviewed or revised Kendle CQA SOPs.
  • Provided consultancy on quality/regulatory related issues for CQA functions.
Quality Management Representative 11/2000 to 05/2004 Biolife Plasma Services/Baxter Healthcare MI
  • Performed routine document review such as; quality control records, inventory logs, donor files, laboratory results, shipping records, and disposal records, to ensure SOP and regulatory compliance.
  • Performed internal auditing of plasma collection processes and procedures to ensure SOPs / cGMP practices are followed in addition to standards established by FDA and QPP are being met.
  • Managed external and internal audits such as FDA, QPP and Baxter Bioscience.
  • Approved and evaluated CAPAs.
  • Corrective and Preventative Actions) Tracked and trended Exception/Variances to SOPs.
  • Trained new Quality Management Representatives.
  • Assisted staff on interpreting and understanding SOPs to ensure compliance.
Quality Assurance Lab Tech I/II 09/1991 to 11/2000 Amway Corporation MI
  • Performed quality inspections of finished products in an in house and supplier setting using various specialized sampling plans such as Mil Standard and NBS.
  • Inspected product to meet established quality standards and performed troubleshooting when necessary.
  • Reviewed processes and procedures of suppliers, particularly food and drug, to ensure cGMP/GLP practices and standards such as CFR, AIB, USP, and USDA/FDA are being met.
  • Assembled drug packets, performed batch releases and retained batch records.
  • Retained and evaluated stability of product.
Education
Course work in Nuclear Medicine Technology 2002 Ferris State University Big Rapids, MI
Phlebotomy Certification (Certification # 191006991003) 1999 Davenport College Grand Rapids, MI
1998 Grand Valley State University Allendale, MI
Bachelor of Science: Physiology 1990 Michigan State University East Lansing, MI Physiology
Associates Degree: Science 1988 Grand Rapids Junior College Grand Rapids, MI Science
Memberships/Scholarly Societies
ASQ-CQA: Certified Quality Auditor through American Society of Quality *ASQ-CPGC: Certified Pharmaceutical GMP Professional through American Society of Quality
Skills
audit reports, clinical trials, database, documentation, external audits, facility management, GCP, GMP, GLP, Good Laboratory Practices, Inspection, internal audits, internal audit, internal auditing, inventory, regulatory compliance, materials, office, Works, Phlebotomy, processes, Project Plans, Protocols, Quality, Quality Improvement, Quality Management, quality control, shipping, SOP, therapy, troubleshooting, Validation
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Resume Overview

Companies Worked For:

  • Emergent BioSolutions
  • Cincinnati Children's Hospital Medical Center
  • Kendle International
  • Biolife Plasma Services/Baxter Healthcare
  • Amway Corporation

School Attended

  • Ferris State University
  • Davenport College
  • Grand Valley State University
  • Michigan State University
  • Grand Rapids Junior College

Job Titles Held:

  • Specialist, GxP Compliance Auditor
  • Senior Research Compliance Specialist
  • Clinical Quality Assurance Auditor I
  • Clinical Quality Assurance Auditor
  • Quality Management Representative
  • Quality Assurance Lab Tech I/II

Degrees

  • Course work in Nuclear Medicine Technology 2002
    Phlebotomy Certification (Certification # 191006991003) 1999
    1998
    Bachelor of Science : Physiology 1990
    Associates Degree : Science 1988

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