Active Listener, Analyst Resume Example
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ACTIVE LISTENER, ANALYST
Skills
Continuous Improvement, Document Management, Procurement, QA/QC Auditor
Experience
July 2013 to July 2014Active Listener, Analyst
- Auditor, Compliance Audit, Continuous Improvement, Contracts Negotiator, Document Management, Staff Trainer, General Office Management, GMP, GLP, Hazardous Waste Coordinator, Safety Inspector, ISO 9000 trained, Calibration Coordinator for Equipment, IQ,OQ, PQ, Shipping/Delivery Coordinator, Personnel Records Management, Pricing, Procurement, Protocols, Quality Control, Quality Assurance, Receiving, Reporting, Researcher.
Next Breath, LLCApril 2008 to September 2011Administrator Assistant & QA Auditor
Oh , STATE
Oh , STATE
- Proficient with cGMP/OSHA/ISO guidelines.
- Audited Study Reports, Final Reports, Study Protocol Binders, R&D Binders, Electronic Files, Analysts notebooks.
- Audit daily to prevent OOS(out of spec),OOT(out of trend), IR(incident report), DR(deviation report) and investigation.
- Analyzed Device History Records (DHR) and Master Batch Records (MBR) and supporting documents.
- 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 to be current with GMP's.
- 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 and processed (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 to prevent over ordering reagent and chemical that reach expiration before use.
- Evaluated the Study Protocols and R & D Protocols to access the validity of the findings.
- Experience with continuous improvement initiatives.
- 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 and with clients.
- Filed all necessary documents to be compliant with Federal and State laws for Hazardous waste disposal.
- Implented orientations screening and compile paperwork for New Hires.
- Issued lab notebook and order lab coat for new hire.
April 2008 to February 2010Quality 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.
- Negotiated pricing for all Office supplies and Laboratory supplies.
- Procurement of all office supplies and Laboratory supplies.
- Communicated effectively with National and International clients on a daily basis.
- Audited commercial clients Study Protocols and R & D Protocols.
- Conducted Safety audits for commercial client laboratories onsite and offsite.
- 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 investigate any discrepancy that may arise such.
Quality Assurance Specialist II
Workflow Coordinator
- reviewed all manufacturing documents that were due for revisions to assure accuracy and compliancy.
- Utilized the quality assurance systems in compliance with current GMP's.
- Managed documents changes through the use of an Electronic Document Management System.
- Created then issued logbooks, lab notebooks, and Solution Prep Records.
- Reconciled documents and checked retention schedule for either Shredding or offsite archiving.
- Submissions of various documents, data entry, maintenance of electronic files and there hardcopies in the FMC archives.
- Prioritized and managed a variety of projects.
- Assisted with internal audits and inspection readiness program.
- POU Manual Coordinator for manufacturing.
- Audited POU Manuals to be cGMP compliant.
- Audited the Archive for cGMP compliancy.
- Archived various types of documents.
- Scanned Records to send to FDA and various clients.
- Interchanged of discussion with Managers and other workers on updating their documents to be compliant with current GMP's.
- AstraZeneca (Medimmune)-Frederick, Md.
- 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.
- Reconciliation of documents issued by the use of Microsoft Outlook reminders.
- Archived documents, logbooks, master records reports, validation documents and various documents then enter the documents into the Access database and Aegis database.
- Archived documents in both building.
- 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.
Education and Training
Towson State University11/2006 01/2006The Rules & Regulation of Workplace Safety and OSHA Compliance Certificate-
*FDA CIDERS -training Certificate-
*Archives and Records Management(ARM)-
*Format and Control of Procedures-
*Aegis Workflow Coordinator Training Course-
*Access and Aegis Training-
*Access and Aegis Security-
*Emergency Awareness Training-
*Change Control Management Certificate -
*Regulatrory Agency and Third Party Inspections Certificate-
*Control of Templates and Forms Certificate -
*Final Quality Risk Assessment and Summary-
*Personnel Signature and Initial Certification/Verification System-
BiologyCity, Stateas 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's (standard operating procedures).
Assisted writing / revising SOP's, protocols, test methods, and reports as
needed.
Quality Assurance Auditor
Diebold Election-Annapolis
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.
Quality Control Analyst
Sterilex Corporation * Owings Mills, Md.
Analyzed research samples and finished product samples line to provide
analytical support for Sterilex product lines.
Performed review/release of batch records, as needed.
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.
Updated Material Safety Data Sheets and laboratory procedures.
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Resume Overview
School Attended
- Towson State University
Job Titles Held:
- Active Listener, Analyst
- Administrator Assistant & QA Auditor
- Quality Assurance Auditor
- Quality Assurance Specialist II Workflow Coordinator
Degrees
- The Rules & Regulation of Workplace Safety and OSHA Compliance Certificate-
*FDA CIDERS -training Certificate-
*Archives and Records Management(ARM)-
*Format and Control of Procedures-
*Aegis Workflow Coordinator Training Course-
*Access and Aegis Training-
*Access and Aegis Security-
*Emergency Awareness Training-
*Change Control Management Certificate -
*Regulatrory Agency and Third Party Inspections Certificate-
*Control of Templates and Forms Certificate -
*Final Quality Risk Assessment and Summary-
*Personnel Signature and Initial Certification/Verification System-
Biology
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