Education

Salem Community College

oLiberal Arts, Associates Degree

Allen School of Health Science

oMedical Insurance Billing and Coding: GPA 4.0

AAPC Member

Summary Qualifications

Proficiency with the AS400 and SAP

Performing AQL on products

Reporting Analysis

EMR Insurance & billing

MasterControl for document control. / Technical File

Data Entry

QA Inspections

Register and prepared patient charts

Prepared and processed more than 120 insurance verifications

Insurance Reimbursement

Inventory control

Managed rework and lean projects.

Knowledgeable with CAR’s and PAR’s process

Maintained FDA Products

Managed inspection activities for Japan product exports

Quality Assurance activities for recall and return products

Quality Tracking System (QTS) TrackWise

Oracle Database

Complaint Intake, Triage and Investigation (CITI)

Complaint Investigation

Cisco WebEx and Skype

Inspection Export/ Import

Corrective Actions and Preventive Actions (CAPA)

ICD-9, ICD-10 & CPT

ISO 13485-2016

Current Good Manufacturing Practice (cGMP)

Global Trade Item Numbers (GTIN )

Nonconformance (NCRs)

Experience

Pfizer / GlaxoSmithKline

Quality Assurance Specialist

May 2019 – current

oAnalyzed Complaint data monthly to identify new and systemic issues as necessary

oEvaluated Complaints to analyze whether an investigation is necessary and when appropriate, participated in those complaint investigation

oFamiliarity with FDA 21 CFR 820 and medical device regulation

oStrong ability to plan, schedule and prioritize own work routine and support the activities at the facility

oOrganizing and determine action to eliminate the causes of potential nonconformities in order to prevent the reoccurrence.

oPlanning and documenting action that is needed

oImplementing action which include updating documentation.

oImplementing corrective and preventive action (CAPA)

oResponsible for processing complaints to ensure quality and compliance with all SOPs, cGMP, company policies as well as FDA and other government and safety regulations by performing the following duties.

oThe primary responsibilities will be to complete complaint reports per the complaint template and governing site procedures.

oThe QA specialist will be responsible for processing and closing complaints in a timely manner.

oInitiates incidents in the investigation system per site procedures as required, i.e. if the complaint has a manufacturing root cause.

oAdditional responsibilities my include write or assisting with manufacturing investigation when required.

oWork with the QA manager to resolve issues associated with complaints or the complaint system.

oProcess and close complaints investigation reports in a timely manner.

oInitiates incidents in the investigation system per site procedures

oApproves the complaint reports per the site procedure

oInterprets generated data and communicate results to Quality management.

oMaintain effective communication and partnership with Operations department.

oInteracts with production, technical services, engineering Quality Control (QC) as part of the investigation process

Boehringer Ingelheim (Aequor)

Quality Artwork Coordinator

September 2018 –May 2019

oGood Manufacturing Practices (cGMP) to ensure the product meet FDA guidelines /standard.

oInspect all inbound Medical products and perform AQL on product to ensure the accuracy of the inventory, and issue and write NCR nonconformance reports.

oLabel the vails with the doses amount, lot number and expiration date

oPrint the Artwork design for the vails and the IFU for various countries.

oAssist with the BIAH label change project.

oAssist with inspection and release of controlled labeling, including cartons and inserts in accordance with applicable regulations and procedures.

oAssist with review of test print artwork and verification that it is correct.

oAssist with review of packaging records/data capture forms for compliance with applicable procedures.

oAssist packaging QA Specialist with other duties as assigned

Sol-Millennium Medical

Quality Assurance Specialist / Associates

January 2018- September 2018

oObtain GTIN (Global Trade Item numbers from the database which developed from GS1 (global Standard One)

oInspect all inbound Medical products and perform AQL on product to ensure the accuracy of the inventory, and issue and write NCR nonconformance reports.

oWrite work instruction procedures for GTIN that follow guide line of the FDA standards

oCreate custom worksheets for inventory control of products in EMEA, APAC, and NACA

oAudited internal SAP and MasterControl for document control databases for products globally

oISO 13485-2016 overview of update to the standard and guideline on how to prepare for the new standard, plus the deadline for recertification that provides an international standard.

oGood Manufacturing Practices (cGMP) to ensure the product meet FDA guidelines /standard.

APL Logistics (Smith & Nephew)

QA Medical inspector/ Returns Specialist Clerk

June 2004-January 2018

oResponsible for leading a team of QA analysts to inspect Smith & Nephew’s medical products to meet FDA and international standards

oGood Manufacturing Practices (cGMP) to ensure the product meet FDA guidelines /standard.

oMaintained confidential records of client’s purchases and maintained a satisfactory inventory of Smith and Nephew’s product line.

oCommunicate daily with customers to ensure that they were able to receive products and that the shipment amount corresponded with the purchase order.

oCoordinate with external customers to create RMA of damaged products

oPerformed AQL on received and shipped for international and local.

oFile claim on damage products from shipments

oFile complaint and investigate for local and international

oLog and document the customer information on returns log

oReview the SOP to ensure that FDA standards regulations for products have are being met.

oMaintained confidential records and communicate via phone and e-mail.

oMicrosoft Operation System 3.1.95.98.00.01, XP, Vista and 7 Microsoft Office Suite: 2003, 2007 and 2010.

oCoordinates with other departments to identify and report and remove any internal or external non-conformance product.

oEnsure accuracy of inventory

oWrite and work on lean project with the departments.

Contact this candidate