Lashanda Washington

*** ******* ** *********, ** 76002

ad4pxw@r.postjobfree.com

313-***-****

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

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

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

PROFESSIONAL EXPERIENCE

Sovereign Pharmaceuticals, Fort Worth TX 11/2020- Quality Assurance Documentation Specialist Lead

Prepared and processed approvals for quality system document changes Redline, Change control

Ensured proper accessibility and maintenance of documents. Ensured proper operation of company-wide software to manage document and training records, tracking, and trending systems

Maintained shared online document systems with active spreadsheets and worksheets

Reviewed physical certified documents and uploaded them electronically using Adobe into the database

Ensured training for document changes, that I created into an organized library system

Scanned and processed files with 800-100 sheets daily, created daily reports of all new processes I performed entered documents electronically

Tracking and archiving of receipts and documents as applicable reviewing batch records

Inspected and reviewed data on new medical devices and calibrated audits

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

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

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 Quality Assurance 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

Processed all Fed Ex and UPS in/outbound deliveries and processed invoices

Carried out the duties of a Quality Inspector for GMP/SOP documentations

Contact this candidate