To obtain a position that will enable me to apply my knowledge and experience in quality compliance.
Specialist, GxP Compliance Auditor11/2013 to CurrentEmergent BioSolutionsLansing, 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 Specialist05/2007 to 11/2013Cincinnati Children's Hospital Medical CenterCincinnati, 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 05/2007Kendle InternationalCincinnati, OH
Clinical Quality Assurance Auditor I05/2004 to 10/2005
Clinical Quality Assurance Auditor02/2006 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.
Wrote, reviewed or revised Kendle CQA SOPs.
Provided consultancy on quality/regulatory related issues for CQA functions.
Quality Management Representative11/2000 to 05/2004Biolife Plasma Services/Baxter HealthcareMI
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/II09/1991 to 11/2000Amway CorporationMI
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.
Course work in Nuclear Medicine Technology2002Ferris State UniversityBig Rapids, MI
Phlebotomy Certification (Certification # 191006991003)1999Davenport CollegeGrand Rapids, MI
1998Grand Valley State UniversityAllendale, MI
Bachelor of Science: Physiology1990Michigan State UniversityEast Lansing, MIPhysiology