Quality Assurance/Quality Control Intern
Resume:
Kashka Bleach
*** ****** **. ******, **. *****
************@*****.***
OBJECTIVE: To obtain a challenging and impactful position in a Government Regulated Industry.
EXPERIENCE: Strong background related to independently managing day to day activities related to Document Control practices in both cGMP regulated and unregulated environments. Participated and assisted the Quality Assurance Department using a quality management system (TrackWise). Worked in cross-functional teams to resolve issues quickly and effectively. Continuous working knowledge of 21CFR820, 21CFR210/211, ISO 13485, ISO 9001 and additional applicable federal regulations such as HIPPA Compliance.
EDUCATION:
Roxbury Community College
Concentration: Bio-Manufacturing Boston, MA
RETS Technical Center Charlestown, MA
Concentration: Electronics and Computer Technology program
ITT Technical Institute Norwood, MA
Concentration: Computer Information Technology
TRAINING:
TrackWise System Continuity Plan
Data Integrity Awareness
Issuance, Distribution, and Control of Documentation
Issuance, Distribution and Control of Batch Production Records & label Accountability Records
Review of Batch Records & Label Accountability Forms
Maintenance and Control of Archived Documents
Records Retention Procedure
Inspection Readiness and Audit Behavior Training
Breach and Recovery of Environmental Control
Receipt, Inspection and Transfer of incoming Biopsies
Procedures for Quality Systems & Training Programs
WORK HISTORY:
Umass Medical School-Massbiologics
Quality Assurance/ Quality Control Intern
Filing and Archiving within cGMP guidelines
Implementing of new IPs, Logbooks, SOPs
Ensure all documents submitted are accurate and final review has been done
Maintain all master files
Update and process documents through Master Control
Access databases that are utilized for tracking and management of the high volume of documentation flowing between related departments
Creates and organizes systems for filing and tracking GMP related records and documentation
Reviews documents to ensure that cGMP documentation meets in-house and cGMP requirements
WSP - Parsons and Brinckerhoff Boston, MA
Accountant Assistant - (Aerotek Staffing Temp) January 2017 – April 2017
Log and track project documents
Research information to complete all documents
Scan, upload and in load all project documents into system using Oracle
Reduce accountants time by extracting all documents and projects that are complete or in final stages
Produce job sheets for projects to be billed from
Review and revise documents from Project Managers and Project Directors
Vericel Corporation (formerly Sanofi-Genzyme) Cambridge, MA
Quality Assurance-TrackWise Data Specialist (Aerotek Staffing Temp) October 2016-November 2016
Participated as a key member of the QA TrackWise implementation and data entry of Deviations, Investigations, CAPA, and Change Control.
Successfully expedited completion of the TrackWise project from 3 months to 1 month.
Archived GMP Documents (i.e. Batch Records and R&D records) as part of the record retention and document control program.
Ensured TrackWise project decisions were made on sound Quality principles and regulatory guidelines related to electronic systems.
Allocated and verified controlled batch records and associated SOPs to manufacturing.
Supported the Site Project Manager with SOP verification related to new product launch.
Tufts Health Plan Watertown, MA
Records/Claims Processor April 2015-May 2016
Received, managed, and allocated paper based medical claims.
Archived medical claim documentation for retention purposes.
Logged and filed medical claims into electronic database
Performed data entry and processed medical claims adhering to strict timelines.
Provided troubleshooting assistance regarding issues with medical claims.
Interacted with multiple levels of staffing
Recommended process improvements to advance the medical claim handling process.
Public Consulting Group Boston, MA
Document Control Specialist-EDI Specialist II November 2010-August 2014
Handled and processed site postal deliveries
Received, sorted, and filed confidential documentation for retention purposes.
Managed medical claims system while ensuring accurate information was maintained.
Trusted with handling of invoices for the Accounting Department
Provided Medicare and Medicaid reimbursement, claims operations workflow documentation.
Met timelines in a fast-paced HIPPA Compliant environment.
Total Clerical Services Boston, MA
Operations Technician July 2010-November 2010
Responsible for processing, sorting, shipment and delivery of corporate mail and packages.
Managed company office supply inventory
Performed light maintenance and troubleshooting for site copiers.
Liaison for site management conference room and office setup and breakdown.
REFERENCES
Traci Almeida - Claims Operations Manager
Public Consulting Group
Phone: 774-***-****
Email: ********@*****.***
Keisha N. Taylor-Manager Quality Operations
Vericel Corporation (Formerly Sanofi-Genzyme)
Phone: 618-***-****
Email: *******@****.***
Jay P. Aldrich-Associate Director-Quality Assurance
Vericel Corporation (Formerly Sanofi-Genzyme)
Phone: 617-***-****
Email: ********@****.***
Contact this candidate