Quality

Maria C. McMurry

**** *. ***** *** *******, Tucson, AZ 85757

520-***-**** *********@*****.***

OBJECTIVE

Highly motivated, quick-learning professional with strong work ethic and extensive years of experience with Quality Systems. Experienced in an ISO 13485 certified Class III medical device company as well as good working knowledge of 21 CFR 820 Quality Management Systems including Quality Assurance, Quality Controls, and Manufacturing and Document Change Control.

SKILLS

Reads, Writes, & Speaks Spanish

Proficient in Microsoft Office Suite

NCR Processing

Material Review Board

Computer proficiency

Final Product Quality Inspection within GMP/ISO environment

Device Tracking & Calibration System

Raw materials sampling and testing as well as contract testing

Record Retention, Good Documentation Practices, Audits

MasterControl (EDMS)

Expandable (ERP System)

Accountability, Quality First

TOOLS

Fiberscope

Calipers

Refractometer

Micrometer

PosiTector

Viscometer Micrometer

Melting Point Analyzer

Karl Fischer Titrator

pH Meter

Microscope

Borescope

Vapor Pressure & Freezing Point Osmometer

PROFESSIONAL EXPERIENCE

SynCardia Systems, LLC – Tucson, AZ

Sr. Heart Quality Technician/Lead October 2008 – March 2020

oIn-process, finished goods, and incoming inspection of manufacturing processes and products, release finished goods shipments to customers based on documented requirements.

oEnsure finished devices consistently meet required quality standards based on documented requirements.

oImplement quality methods and drive the use of quality tools in manufacturing. Assist in resolving quality issues.

oDevelop and implement methods and procedures for disposition of discrepant materials.

oParticipate in technical writing and document change control in support of clean room related processes.

oParticipate in measuring and testing product and tabulating data concerning materials, product or process quality and reliability

oWrite non-conforming reports for discrepant material and disposition accordingly. Initiate action and recommend solutions to prevent the occurrence of nonconformities relating to the product, process and Quality System. Verify the implementation of solutions.

oInspect and review Device History Records to ensure compliance with regulatory requirements prior to release of finished goods.

Stanadyne Corporation – Jacksonville, NC

Quality Inspector February 2008 – September 2008

oReceiving Inspection of raw materials used for the production of fuel pumps for engine applications in agriculture, construction, power generation, industrial, marine, and on-highway vehicles.

SAIC Federal Wireless Range Instrumentation Division – San Diego, CA

QA/Product Support Associate February 2006 – December 2007

oPerform Configuration Management/Document Control

oLogistics tracking of all material returned to SAIC for all projects.

QA Technical Analyst II February 2002 – February 2006

oMaterial Control: maintain stock and non/stock utilizing WSG Inventory program (Access).

oPerform Goods Receipt processing utilizing SAP R/3 software.

oBack-up for QA Receiving Inspection, QA code assignments for Purchase Requisitions.

QA Specialist III April 2001 – January 2002

oReceipt/tracking/resolution of nonconforming materials processed.

oShipping documentation, coordination, and supervision of delivery processes for all domestic and international projects.

oCalibration upkeep of group equipment and main point of contact with calibration service agency.

oReceipt/tracking of inventory for government, customer and subcontractor furnished property for all programs.

oDatabase maintenance, network folder updates, document control/distribution for above-mentioned tasks.

oISO input for procedures, work instructions and forms related to QA functions.

oInterface with various organizations.

Nextran, Inc. (formerly Cytel Corporation) – San Diego, CA

cGMP Materials Coordinator April 1999 – January 2001

oResponsible for the operation of the company's 7,600 sq. ft. cGMP licensed Materials Management facility.

oPerformed and managed physical and administrative tasks involved in the receiving, inventory, storing, and, distributing of GMP raw materials and components in compliance with Standard Operating Procedures.

oProcessed GMP materials to support the manufacture of drug products.

oPrepared and updated applicable Standard Operating Procedures.

oPerformed deliveries of GMP materials and Just-in-Time deliveries to the manufacturing facility.

oPrimary Purchasing Liaison for both Manufacturing and Materials Management facilities. Ordered GMP raw materials/components following QC specifications, in addition to ordering non-GMP supplies.

Cytel Corporation – San Diego, CA

Quality Control Analyst April 1996 – April 1999

oResponsible for scheduling, sampling, and testing of cGMP raw materials and components, and training of back-up personnel.

oCoordinated testing and reviewed accuracy of test results from contract laboratories. Initiated any changes and/or additions required.

oPrepared data summary and test results documents for approval by manager and QA.

oCoordinated test priorities and schedules with Manufacturing.

oPerformed release testing following Q.C. Test Protocols and Standard Operating Procedures.

oPrepared QC Raw Materials Specifications. Assisted in the preparation and review of QC Protocols and Standard Operating Procedures.

oAssisted in sampling and release testing of stability material, intermediate and final drug products.

oPerformed ongoing water sampling of various ports of facility's deionized water system; packaged and shipped samples to contract test labs; reviewed test data for completeness and accuracy, and prepared data summary and test documents for approval by QC Director.

oParticipated in departmental cGMP compliance and maintained accurate records/documentation of laboratory activities.

Quality Control Assistant August 1994 – June 1996

oParticipated in tasks required for cGMP compliance.

oParticipated in testing of raw materials for use in cGMP manufacturing; sampled and shipped raw materials to contract test labs; reviewed data for completeness and prepared test documentation for review.

oInspected components for use in manufacturing.

oConducted temperature monitoring for department temperature-controlled equipment and maintained required documentation.

oSet-up filing system for raw materials test data.

Executive Assistant/Office Manager July 1992 – July 1994

Fujitsu/ICL Customer Service – La Jolla, CA

Executive Secretary / Corporate Finance Dept. December 1991 – June 1992

Ernst & Young – San Diego, CA

Executive Secretary / Tax & Entrepreneurial Services November 1990 – November 1991

Great American Bank – San Diego, CA

Administrative Assistant / Corporate Tax Dept July 1989 – November 1990

Price Waterhouse – San Diego, CA

Tax Secretary / Bookkeeping Assistant January 1988 – June 1989

Receptionist / Secretary November 1986 – December 1987

Prior experience in the Legal Collections field, Tucson, AZ January 1983 – September 1985

oProvided administrative assistance to attorneys/paralegals with legal collections and domestic law.

oNotary Public for various legal documents.

oPrepared collections letters, general court pleadings/documents, and wills.

oTracked recorded legal fees and expenses for each corporate client and issued monthly billing statements.

oLight skip-tracing utilizing various methods of locating debtors.

oUtilized system for tracking payments due from debtors.

oExtensive communication with many Arizona county courthouses and officials for serving court documents on debtors.

oScheduled and organized meetings with clients and debtors.

oBack-up to Receptionist utilizing multi-line phone system to serve 15 personnel.

EDUCATION

Cholla High School – Tucson, AZ June 1983

High School Degree

Contact this candidate