| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLEOBJECTIVE:Highly motivated individual seeking an opportunity to lead and execute within a team-driven environment by supporting process improvement efforts and effectively determining the most efficient ways for output in order to provide world-class service, delivering real improvements that positively impact the company's bottom line through a combination of expertise in quantitative methods and experience across all business functions.CERTIFICATION(S):FDA-EDA, AS-9100, AS-400, Quality Inspector Auditor, CAD, ARMS, Engineer Specialist SAP, ForkliftISO9001/14001 and 1345SOFTWARE EXPERIENCE:ERP, EMR, MRP, EDI, JDE, ASC Track, Tandem, Aims, SAP, Record keeper, True View, Microsoft Office CTD /ECTD, Documentation, Adobe Acrobat Pro MMS32, Day Force, Dynamics SL, Citrix1, Outlook, Blue beam, Oracle, Agile, SQROL, Smart loader, Zendesk, Sales forcePROFESSIONAL SKILLS:Over 8+ years Supplied Chain, Pharmaceutical, Warehouse, Documentation, and Quality AssuranceForklift, SOPs, GMPs, Scanning, Order Details, Dimensions, UV Spectroscopy, accounts redlinesProcessed Records Review (i.e. reviewed drawings charts, managed computer system, and quality experience) CTD/ Electronic submission, validatedChart Batch Audits, Electronic Records Reviews, Chart Chasing, Monitoring, Analysis MetricsDocumentation professional with coding and SAP experience, uploaded and submitted documentationData entry, ability to type and handle high volume telephone calls, records, and invoice payments.Software Systems: Quality Inspector Audit Certified, Laboratory testing, Calibrated, Utilized DCCR, PSSR, and PSI documentation, Cargo and porter driverPROFESSIONAL EXPERIENCESovereign Pharmaceuticals, Fort Worth TX 11/2020- Quality Assurance Documentation Specialist LeadPrepared and processed approvals for quality system document changes Redline, Change controlEnsured proper accessibility and maintenance of documents. Ensured proper operation of company-wide software to manage document and training records, tracking, and trending systemsMaintained shared online document systems with active spreadsheets and worksheetsReviewed physical certified documents and uploaded them electronically using Adobe into the databaseEnsured training for document changes, that I created into an organized library systemScanned and processed files with 800-100 sheets daily, created daily reports of all new processes I performed entered documents electronicallyTracking and archiving of receipts and documents as applicable reviewing batch recordsInspected and reviewed data on new medical devices and calibrated auditsDJO Global, Lewisville, TX 07/2019 10/2020Document Record Indexing SpecialistProcessed and reviewed electronic files and documents. Identified labels, managed electronic documentsPerformed regular daily maintenance of scanner documents from the office and insurance companyMet quality deadline standards as needed, index batches of data once scanned. Processed electronic files. Audited for compliance in accordance with state/federal guidelines.Indexed and stored clients documents while maintaining security and confidentialityReviewed Quality Assurance standards and processed 200 files a day or moreAudited for accuracy/errors Customer care processed returns, assist in the analysis of supplierMarathon Petroleum Co., Detroit, M 03/2018 12/2018Refinery Document Control Engineer SpecialistProvided input on old refinery drawings on adding and deleting lines of auto CAD work ordersCollaborated within different engineering teams, and entered documents and data for the contractors jobProvided input on document enhancement and retention, and maintained ISO systems; along with office dutiesProcessed audits, collected and reviewed elevations to verified projects for releases and Database entriesImported and exported different functions and ran data to generate daily reports based on drawings and documentsEntered approval orders with details into MGT databaseProcessed drawings details and elevation bubble to calculate dimensions to create panels orders confirmation sheetMolina Healthcare, Inc., Troy, MI 01/2018 05/2018Hedis Quality Document SpecialistCoordinated, collected and evaluated clinical & non-clinical quality documents, met timeline establishedReceived and processed quality of care, organized data collection, oversaw medical recordsRequested referrals of records from the appropriate source, reviewed and analyzed referralsLogged and tracked reports, recorded and reviewed appointments, and performed daily out & inbound phone callsReviewed charts and ensured project loads were adequate and organizedReviewed NCQA standards, prepared narrative graphs, charts and flow charts, accounts receivable reportsProvided information to physicians and providers, performed high level of data entryAmerisourceBergen, Memphis, TN 01/2015 09/2017Regulatory FDA Analyst Documentation SpecialistHeld responsible for quality reviews and audits of completed batch records under FDA/DEAUtilized, established guidelines and SOPs and GMPs, calibrated lab machinesReviewed and approved 95+ batch records with laboratory test data dailyProvided feedback to the quality management team on the results of quality auditsConducted claim research, determined corrective services locationEducated members and providers to ensure that specific metrics were addressedAudited charts and reviewed GMP safety guidelines of ensuring qualityContinued process improvement on batch records and reviewed ICD/CPT coding guidelinesEnsured accuracy and integrity of information per NCQA guidelinesEntered information into an assigned database using FDA regulatory requirementsProvided on-site pharmaceutical records retrieval for batch and laboratory dataEnsured all information received and entered met established standardsWorked with the Quality Assurance department to identify trendsPerformed batch chart reviews and audits for goods to be prepared for shippingKelloggs, Memphis, TN 07/2015 03/2016Data Entry Specialist/Warehouse supplyPrepared sourced data for entry using the SAP database system Processes documentation for repair items and warranty claimsReviewed documents for errors and accuracy on incoming product for inventory.Resolved discrepancies, operated a high low machine to move product to dock locationsEntered tracks, monitored customer material that we order or was returnedVerified receipts against deliveries, loaded trucksProcessed all Fed Ex and UPS in/outbound deliveries and processed invoicesCarried out the duties of a Quality Inspector for GMP/SOP documentations |
