Quality Assurance Manager
Resume:
Gwendolyn Leake
Concord, NC *****
PROFESSIONAL EXPERIENCE:
August 2014 to May 2015
Aerotek-Rockville, Md.
Quality Assurance Auditor
Assisted with internal audits of manufacturing documents.
Scanned Batch records and various supporting documents.
Packed documents to be stored at an offsite facility then created the chain of custody report in accords to FDA regulation.
Audited documents for any discrepancies, corrected and updated data files in compliance with CGMP’s.
April 2012 to June 2014
AstraZeneca (Medimmune)-Frederick, Md.
June 2013 to June 2014, Quality Assurance Specialist II
Workflow Coordinator reviewed manufacturing documents that were up for revisions.
Managed documents changes by utilizing the Electronic Document Management System (Access and Aegis database).
Answered phones and clients request for information concerning their documents.
Greeted clients entering the QAD office.
Created logbooks and, lab notebooks for the clients.
Reconciled documents and checked retention schedule for Shredding or offsite archiving.
Handled submissions of various documents, data entries of these documents then maintained electronic files and then filed hardcopies in the FMC archives.
Prioritize and manage a wide variety of projects.
Coordinator for manufacturing POU Manual.
Audited the Archive for CGMP compliancy.
Archived various types of documents.
Managed all personnel training records.
Scanned Records to send to FDA and various clients.
Interchange with Managers and other workers on updating their documents to be compliant with CGMP practices.
April 2012 to June 2013, Quality Assurance Documentation Support
Distributed documents to the Point of Use (POU) Manuals for new releases and effective documents.
Created Control Documents Collections Reports for tracking documents, table of contents, work instructions and job aids.
Audited archived documents in the database and hard files.
Packed the offsite document into offsite boxes to be stored at an offsite facility then creating a chain of custody report for filing offsite and onsite.
Supported both Archive sites at Medimmune.
Created Logbooks, Lab Notebooks then issued them to their assigned owner
March 2008 to August 2011
Next Breath, LLC Baltimore, Md.
January 2010 to August 2011, Administrator Assistant & QA Auditor
Proficient with CGMP /OSHA/ISO guidelines
Communicated effectively with multiple clients on an international basis and national basis.
Front desk receptionist, greeted clients, answered phones then directed calls to the prospective departments.
Audited Study Reports, Final Reports, Study Protocol Binders, R&D Binders, Electronic Files, Analysts notebooks. Consistently auditing cut down showed our clients we were committed to delivering the highest industry standards.
Review Device History Records (DHR) and Master Batch Records (MBR) and supporting documents.
Facilitated “no-fault” internal and external audits on various issues because of sound record keeping and thorough documentation.
Monitor the material release criteria, packaging, Certificate of Analysis and processed goods.
ISO 9000 trained
Initiated and maintained all staff training and re-training records in accords CGMP.
Procurement of all laboratory equipment, lab supplies and office supplies.
Managed vendors/suppliers relations, as well as negotiated contracts for pricing. Renegotiated Pricing and payment terms with some suppliers/vendors from Net 0 to Net 60 days. Improved cash flow and helped facilitated company’s profitability.
Created Purchase orders for both commercial and research client’s supplies.
Managed the accurate and timely processing of (up to 200/month) invoices and purchase orders ($1500 general office supplies and $20,000 or greater for research equipment and supplies)
Implemented a thorough cross checking list of supplies, receipts and invoices that halted a previous history of over ordering reagent and chemical that reach expiration before use. In addition, it cut down on unnecessary hazardous waste disposal fees.
Evaluated the Study Protocols and R & D Protocols to access the validity of the findings.
Analyzed the finding to see if an Investigation or a Deviation was necessary to complete the audit.
Experience with continuous improvement initiatives such as Kaizen.
Managed vendors/suppliers relations.
Maintained adherence to industry standards for the calibrations of all the research and laboratory equipment. Scheduled calibration maintained Next Breath efficiency with the startup of all projects.
Coordinate meeting with staff, with clients through various means.
Coordinate the removal of Hazardous waste from the facilities and filed all necessary documents to be compliant with Federal and State laws.
Conduct new hire orientations and compile paperwork for Quality Assurance Manager.
Issued lab notebook and order lab coat for new hire.
Safety Auditor for the several of the Labs.
March 2008 to January 2010, Quality Assurance Auditor
Document management of all personnel and customer documents.
Coordinated delivery of products and good by Fed-Ex
Maintained and coordinated the all calibration of all Laboratory equipment
Scheduled all IQ, OQ, PQ, and PM to maintained CGMP on equipment used.
Maintained all data files electronically and hard copies.
Communicated effectively with multiple clients on an international basis and prepare delivery of all samples sent back to the clients.
Audited commercial clients Study Protocols and R & D Protocols.
Coordinated safety audits of all the various laboratories and maintained the reports (on an average of 12 times per year) that contributed to consistently low levels of safety incidents that occurs.
Provided timely, courteous and knowledgeable response to information requests; screened and transferred calls; and prepared laboratory correspondence.
Performed audits of Study Protocols binders, R & D data, lab notebooks, and spreadsheets of test performed at Next Breath, LLC.
Reviewed all written protocols and test methods to ensure compliance.
Assisted Lab Manager to when reviewing all investigational issues that may arise such as incident reports, deviation reports, and out of spec or out of trend to ensure proper documentation.
Trained Analyst on the use of CGMP, CGLP (current good manufacturing practice and current good laboratory practice) and the proper use of SOP (standard operating procedures).
Assisted writing / revising SOP’s, protocols, test methods, and reports as needed.
Safety inspector for the QA laboratory.
April 2006 to November 2006
Diebold Election-Annapolis, Md.
Quality Assurance Auditor
Worked with QA manager to develop audits and audit metrics for tracking performance of Voter outreach event for facilitators and for trainer.
Conducted onsite audits of training classes and Voter Outreach Events.
Assisted QA manager in developing new processes, documentations, and metrics.
Analyzed the finding to see if an Investigation or a Deviation was necessary to complete the audit.
Wrote objectives reports based on audit findings.
February 2000 to January 2006
Sterilex Corporation-Owings Mills, Md.
Quality Control Analyst
Analyzed research samples and finished product samples line to provide analytical support for Sterilex product lines.
Answered phones then directed calls to the prospective department
Procured Certificate of Analysis for raw materials needed for final products.
Procured all Laboratory supplies and equipment.
Performed Comparative Stability Studies on all Company products to uphold and assured the highest quality of testing for Sterilex products.
Created a Receiving Module for all laboratories and all raw materials that was in Sterilex warehouse.
Calibrated laboratory equipment.
Created and maintained a data record log for all samples results.
Record organization contributed to an ease of regulatory compliancy.
Safety inspector for the QA laboratory and the warehouse..
Updated Material Safety Data Sheets and laboratory procedures.
PROFESSIONAL EXPERIENCE CONTINUED:
January 1999 to January 2000, Atlantic Pharmaceuticals-Columbia, Md. Quality Assurance Auditor
November 1995 to November 1998, ECC International-Cockeysville, Md. Quality Control Technician
July 1994 to November 1995, EA Engineering, Science & Technology, Sparks, Md. Chemistry Technician
January 1993 to June 1994, McCormick & Co. Flavor & Manufacturing Division, Hunt Valley, Md. Quality Control Technician
June1984-August 1989, W.R.GRACE- Davison Chemical Division-Curtis Bay, Md. Chemical Analyst III
EDUCATION:
Towson University- Towson, MD
3 years-Biology Major
PROFESSIONAL DEVELOPMENT:
Train the Trainer Certificate-2008
Self-Inspection Audits-2013
The Rules & Regulation of Workplace Safety and OSHA Compliance Certificate-2009
FDA CIDERS-training Certificate-2010
Proficient with CGMP/CGLP/ISO Guidelines
Monitored the material release criteria, packaging, Certificate of Analysis and processed components.
Implementation of training of new hires on CGMP/CGLP for company procedures.
GMP Document and Records Retention-2013
Document Archive Management-2013
Archives and Records Management(ARM)-2013
Format and Control of Procedurs-2013
Aegis Review/Approved Traininig-2013
Aegis Workflow Coordinator Training Course-2013
Aegis View/Print Training-2013
Access and Aegis Security-2013
Control of QAD Work Instructions, Logbooks, and Laboratory Notebooks-2013
Emergency Awareness Training-2013
GMP Quality Compliance Audit Program-2013
Reporting Non-Comformances-2013
Change Control Mangement-2013
QA Control of POINT OF USE MANUALS-2013
Final Quality Risk Assessment and Summary-2013
Extension Reporting and Management-2013
Control of Templates and Forms-2013
Personnel Signature and Initial Certification/Verification System-2013
Regulatory Agency and Third Party Inspections-2013
References are available upon request.
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