Quality Assurance Technician

Margaret R. Mangano

Cell: 978-***-**** Email: ******.****@*****.***

Experience

**/** ** **/** Genzyme/Sanofi Pharmaceuticals, Framingham, MA

Quality Assurance Senior Compliance Specialist

QA for MFG of media, cell culture and downstream purification.

QA disposition and release of final product.

Issue and review batch records, forms, labels and test results.

Initiating and reviewing deviations, investigations and CAPA's.

Train and lead Compliance Specialists on quality assurance

operations.

Ensure GMP documentation is consistent with corporate and regulatory

standards.

Perform MFG suite audits and provide guidance for resolutions and

compliance.

QA support for facilities regarding action notices and MFG

maintenance. Revise, review and approve SOP's, batch

records and various documents.

02/09 to 03/11 Shire Pharmaceuticals, Inc. Lexington, MA

Quality Assurance Specialist

Perform MFG suite audits and provide guidance for resolutions and

compliance.

Conducted investigations, reported findings, and managed deviation

triage meetings.

Initiating, reviewing and closing deviations and CAPA's.

Issue and review batch records, forms, labels and test results.

Ensure GMP documentation is consistent with corporate and

regulatory standards.

Team Lead MFG Associate mentoring coworkers in the execution

of MFG processes.

Assist supervisor with input on employee performance and professional

growth.

Attend morning production meetings with upper management.

Revise, review and approve SOP's, batch records and various documents.

Troubleshoot issues on the floor with equipment and MFG processes.

06/02 to 08/08 Wyeth BioPharma, Andover, MA

Lead Cell Culture Technician

Responsible for all activities in inoculation lab for start up of

clinical campaigns.

Project lead for acquiring multi-product approval for inoculation

lab.

Assisted with commissioning testing in new biotech suite, (IQ/OQ, SAT

testing).

Supported validation activities including SCADA implementation and

testing.

Process Technician for 100L, 500L and 2500L bioreactors.

Set up and evaluation of unit operations such as CIP and SIP as well

as other operations.

Performed aseptic sampling and conducted testing.

Engineering Records Coordinator

Coordinated preventive maintenance schedules and job plans for

equipment.

05/95 to 06/02 Raytel Cardiac Services, Windsor, CT

Field Service Technician

Assisted with sales and service of heart monitors in hospitals and

doctors offices.

Assisted arrhythmia lab in managing and reading cardiac tapes from

monitors.

Maintained heart monitor inventory in New England states.

Consulted with cardiologists and staff to introduce and train on

heart monitors.

Dealt with managed care providers and third party payers.

05/90 to 05/95 National RX Services, Inc. Wilmington, MA

Call Center Representative

Handled incoming calls while adhering to metrics and quality

expectations.

Assisted Blue Cross & Blue Shield with claims processing.

Performed outbound calls to clients to maximize pharmacy mail order

benefits.

Offered resolutions to questions and transferred inquiries to

pharmacists as necessary.

Education

BA / International Business Administration. American

Intercontinental University.

Certifications

Project Management Certificate / Rockhurst University

Critical Thinking Program / BPI Business Processes Inc.

EKG Training Program / Boston Medical Center

Certificate of Appreciation / American Heart Association

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