OBJECTIVE:

To obtain a challenging and impactful position in a highly Government Regulated Industry.

SUMMARY:

Strong background related to independently managing day to day activities related to Document Control practices in both cGMP regulated and unregulated environments. Capable of managing multiple projects. Comfortable working in a "virtual" environment. Participated and assisted the Quality Assurance Department using a quality management system (TrackWise, Veeva, CATSWeb). 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

WORK HISTORY:

Confidential, Norwood, MA

Quality Assurance Document Specialist

Responsibilities:

• Document Control in e-System
• QMS system management/maintenance
• Document Archival
• Metrics support
• Internal customer engagement
• Legacy archive room decommissioning
• Scanning Executed documents

Confidential, Cambridge, MA

Quality Systems Contract Specialist

Responsibilities:

• Manage quality management system record archives for all GxP functions
• Process and File GxP Controlled Documents
• Track and trend deviations, change controls, temporary changes, CAPA and product complaints to closure.
• Assist in the implementation and support of an electronic QMS system as needed.
• Provides record management support during regulatory agency inspections and audits.
• Exercise professional written and verbal communication skills in supporting customer and team members’ needs.
• Assist internal customers in formatting of Procedural Documents as needed
• Exercise professional written and verbal communication skills in supporting customer and team members’ needs

Confidential, Cambridge, MA

Quality Assurance Compliance

Responsibilities:

• Label making for manufacturing and final packaging
• Archiving and Retrieval of files from Iron Mountain
• Implementing of new batch records, Logbooks, and SOPs
• Prepare biopsy accessioning kits
• Prepare batch records for media and cell culture processing
• Review and close out batch records
• Update documents and spreadsheets in EDMS
• Review inspection records for all biopsies received
• Allocated and verified controlled batch records and lot numbers associated with manufacturing
• Assign batch records and lot numbers
• Ensure all documents submitted are accurate and final review has been done
• Act as a key member for QA for TrackWise implementations.
• Data entry of Deviations, Investigations, CAPA, and Change Control

Confidential, Somerville, MA

Quality Assurance Assistant

Responsibilities:

• Sort and file batch records
• Assist with backlog of batch records
• Verify and review batch records for final release
• Track and log all batch records
• Reduce a high volume of backlog down to current date within 6 weeks
• Prepare files for destruction and archiving

Confidential, Boston, MA

Quality Assurance/ Quality Control Intern

Responsibilities:

• 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

Confidential, Boston, MA

Accountant Assistant

Responsibilities:

• Log and track project 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

Confidential, Cambridge, MA

Quality Assurance-TrackWise Data Specialist

Responsibilities:

• 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.

Confidential, Watertown, MA

Records/Claims Processor

Responsibilities:

• 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.

Confidential, Boston, MA

Document Control Specialist-EDI Specialist

Responsibilities:

• 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.

Confidential, Boston, MA

Operations Technician

Responsibilities:

• 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.