Customer Service Quality Control

Richard E. Curtis

*** ************ *** 857-***-****

Roslindale, MA 02131 **********@*****.***

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Qualification Summary:

. Self - directed capable of independent decision-making

. Strong work ethic

. Extensive cleanroom experience

. Successfully led / participated in numerous audits

. Focused on dependable customer service

. Committed to clear and timely communication to ensure tasks are

completed accurately and promptly

. Interacted professionally with internal and external customers

. Experienced with Microsoft Word, TrackWise, LIMS, MFG/PRO, e - Workflow

and e - Procurement

Experience

Genzyme Biosurgery

Cambridge, MA

Senior Quality Inspector 2006 - 2011

. Led Raw Materials group in site audits (FDA, ISO, German Regulatory

Agency, Genzyme Corporate Quality) demonstrating various raw materials

functions resulting in FDA approval of Carticel product

. Improved communication with functional groups at multiple sites

including shipping / receiving, QA, materials management and

manufacturing to ensure orders were filled and shipped on time

Quality Inspector Level II 2002 - 2006

. Resolved materials issues and initiated CAPA's when needed by

contacting outside vendors

. Created, revised and implemented material specifications

. Successfully completed training of new hires in various QC tests and

procedures

Quality Inspector Level I 1997 - 2002

. Ensured seamless flow of goods to an FDA monitored cGMP facility

inspecting, sampling and dispositioning incoming raw materials per

SOP's and specifications within strict time lines

. Provided monitoring of various stages of processing including batch

record review along with frequent trips into an FDA licensed cleanroom

Technician 1995 - 1997

. Supported Quality Control operations by providing services such as

environmental monitoring, water sampling / testing and sample

submission to contract laboratories

. Performed lab support activities with operation of autoclaves and

glass washing machines

Cellcor, Inc.

Newton, MA

Shipper / Receiver

1991 - 1995

. Successfully maintained responsibility for timely shipping and

receiving human blood products manufactured in a cGMP environment

utilized in FDA approved clinical trials for treatment of renal cell

carcinoma

. Provided assistance to QA/QC department inspecting, tracking, and

releasing raw materials used in the manufacturing process

Transporter

1992 - 1995

. Ensured timely transport of human blood products from various clinics

to the Newton lab for processing and ultimately delivering product

back to clinic / patient when ready

. Improved various procedures for facilities maintenance in preparation

for inspections by U.S. government regulatory agencies

Volunteer Community Service

Pine Street Inn Community Servings Earth Day

Boston, MA Jamaica Plain, MA Boston, MA

Kitchen Assistant Kitchen Assistant Clean

up various Charles River sites

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