Quality Assurance Inspector
Resume:
Lashanda Washington
Arlington, TX *****
**.**********@*****.***
OBJECTIVE:
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, Forklift
ISO9001/14001 and 1345, 21 CFR 211,210
SOFTWARE 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 force
PROFESSIONAL SKILLS:
Over 8+ years Supplied Chain, Pharmaceutical, Warehouse, Documentation, and Quality Assurance
Forklift, SOPs, GMPs, Scanning, Order Details, Dimensions, UV Spectroscopy, accounts redlines
Processed Records Review (i.e. reviewed drawings charts, managed computer system, and quality experience) CTD/ Electronic submission, validated, Perform product release process, lab testing,
Chart Batch Audits, Electronic Records Reviews, Chart Chasing, Monitoring, Analysis Metrics
Documentation professional with coding and SAP experience, uploaded and submitted documentation
Data 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 driver, Medical device ordering.
PROFESSIONAL EXPERIENCE
Sovereign Pharmaceuticals, Fort Worth TX 11/2020- Quality Assurance Specialist Lead/ Assistant Supervisor
Prepared and processed approvals for quality system document changes Redline, Change control
Ensured proper accessibility and maintenance of documents. Ensured proper operation, meet schedule deadlines weekly, upload training records, tracking, and trending systems, assist with team time entered
Maintained shared online documents with vendors and clients. Process corrective action with associates
Reviewed physical certified documents and uploaded them electronically using Adobe into the database
Ensured training for new hirers, Implemented a new interview process for QC&QA
Work on the floor as QC inspector, created daily report, performed entries electronically, perform Quality checks & audits in production and laboratory. Conduct daily team meetings, attend upper mgt meetings
Inspect and review data on new medical devices, perform calibration audits in the warehouse,
DJO Global, Lewisville, TX 07/2019 – 10/2020
Document Record Indexing Specialist
Processed and reviewed electronic files and documents. Identified labels, managed electronic documents
Performed regular daily maintenance of scanner documents from the office and insurance company
Met 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 confidentiality
Reviewed Quality Assurance standards and processed 200 files a day or more for Medical device orders
Audited for accuracy/errors Customer care processed returns, assist in the analysis of supplier
Marathon Petroleum Co., Detroit, M 03/2018 – 12/2018
Refinery Document Control Engineer Specialist
Provided input on old refinery drawings on adding and deleting lines of auto CAD work orders
Collaborated within different engineering teams, and entered documents and data for the contractor’s job
Provided input on document enhancement and retention, and maintained ISO systems; along with office duties
Processed audits, collected and reviewed elevations to verified projects for releases and Database entries
Imported and exported different functions and ran data to generate daily reports based on drawings and documents, create, revise, review and approve standard operating procedures.
Entered approval orders with details into MGT database
Processed drawings details and elevation bubble to calculate dimensions to create panels orders confirmation sheet
Molina Healthcare, Inc., Troy, MI 01/2018 – 05/2018
Hedis Quality Document Specialist
Coordinated, collected and evaluated clinical & non-clinical quality documents, met timeline established
Received and processed quality of care, organized data collection, oversaw medical records
Requested referrals of records from the appropriate source, reviewed and analyzed referrals
Logged and tracked reports, recorded and reviewed appointments, and performed daily out & inbound phone calls
Reviewed charts and ensured project loads were adequate and organized
Reviewed NCQA standards, prepared narrative graphs, charts and flow charts, accounts receivable reports
Provided information to physicians and providers, performed high level of data entry
AmerisourceBergen, Memphis, TN 01/2015 – 09/2017
Regulatory FDA Analyst Documentation Specialist
Held responsible for quality reviews and audits of completed batch records under FDA/DEA
Utilized, established guidelines and SOPs and GMPs, calibrated lab machines
Reviewed and approved 95+ batch records with laboratory test data daily
Provided feedback to the quality management team on the results of quality audits
Conducted claim research, determined corrective services location
Educated members and providers to ensure that specific metrics were addressed
Audited charts and reviewed GMP safety guidelines of ensuring quality
Continued process improvement on batch records and reviewed ICD/CPT coding guidelines
Ensured accuracy and integrity of information per NCQA guidelines
Entered information into an assigned database using FDA regulatory requirements
Provided on-site pharmaceutical records retrieval for batch and laboratory data
Ensured all information received and entered met established standards
Worked with the QA & QC’s department to identify trends
Performed batch chart reviews and audits for goods to be prepared for shipping
Kellogg’s, Memphis, TN 07/2015 – 03/2016
Data Entry Specialist/Warehouse supply
Prepared sourced data for entry using the SAP database system Processes documentation for repair items and warranty claims
Reviewed documents for errors and accuracy on incoming product for inventory.
Resolved discrepancies, operated a high low machine to move product to dock locations
Entered tracks, monitored customer material that we order or was returned
Verified receipts against deliveries, loaded trucks, process warehouse audits & inventory
Processed all Fed Ex and UPS in/outbound deliveries and processed invoices
Carried out the duties of a Quality Inspector for GMP/SOP documentations, vendor ordering
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