Manager Quality
Resume:
LINDA LAMBIASE
Ringwood, New Jersey 07456
Phone 862-***-**** *****.********@*****.***
http://www.linkedin.com/pub/linda-lambiase
SUMMARY
Versatile Quality Compliance professional with expertise in the development
and management of marketing communications material. Contributing both
team and management experience within a team-based environment focused on
the accuracy, integrity, production and data management of marketing and
collateral material. Knowledge and experience with FDA, CAPA and ISO
requirements.
THE MEDILOGIC GROUP LLC, Prospect Park, NJ 2012 - Present
Manufacturing Liaison
Plan, schedule and manage the manufacturing of product from machining to
delivery.
. Schedule and manage production flow through shop floor to ensure timely
delivery of finished product.
. Developed tracking database for production visibility and scheduling.
. Maintain customer job assignment files, assigning documentation for
manufacturing operations and certification requirements to Quality
Assurance procedures for finished product.
. Provide manufacturing and delivery status updates to customers.
. Assign operation process paperwork to customer drawings for production.
. Perform internal audits and CAPA requirements.
. Revise quality procedures and training to manufacturing per ISO
Standards as required.
. Tooling and raw material purchasing.
. Perform laser welding and laser marking operations as required.
STRYKER ORTHOPAEDICS, Mahwah, NJ 1984 - 2011
Manager, HealthCare Innovations Quality and Compliance (2005 - 2011)
Managed and maintained a review and approval content management system for
product literature.
. Facilitated the development of an on-demand ordering system for
marketing collateral for both U.S. and International use.
. Indentified and maintained the process flow of literature inventory from
distribution warehouses toward the electronic on-demand system.
. Worked with product marketing team material owners to reduce paper
material and ensure accuracy of electronic material reducing inventory
and waste by 40%.
. Partnered with print vendor for back-end hierarchy for accurate
placement of product into electronic ordering systems.
. Achieved literature backorder reduction and significant reduction in
distribution storage costs.
. Developed and completed various internal procedures to reflect
processes.
LINDA LAMBIASE
Page 2
Phone 862-***-**** *****.********@*****.***
http://www.linkedin.com/pub/linda-lambiase
. Worked with multi-functional teams to complete CAPA.
. Carried out team functions as procedural training coordinator.
Senior Traffic Manager (2000 - 2005)
Led the development of an internal content review and approval system for
marketing material with emphasis on Quality Compliance. Fostered the
creative design team through job scheduling process for more accurate and
timely content designs and edits.
. Carried out the development of an electronic review system for
increasing first pass yield and accuracy through reviews. Developed
the documentation of this process.
. Fostered proof reading services with vendor and team for accurate
content.
. Developed reviewer metrics through relationships with Regulatory and
Legal review teams, for better first-pass yield of content and more
efficient turn-around time.
STRYKER ORTHOPAEDICS, Mahwah, NJ (1984 - 1999)
Supported a variety of functional areas within the company, from Quality
Assurance Support, through Packaging Team Support to Manufacturing - with
functions ranging from Packaging labeling development and translations of
instructions for use, to buying, scheduling and warehousing.
. Developed and designed a packaging labeling system, including
translations and approval of content.
. Designed a package insert dictionary.
. Completed purchasing and buying functions for packaging team.
EDUCATION
BA, Communications, Seton Hall University, South Orange, NJ
TECHNICAL SKILLS
MS Office (Word Excel PowerPoint)
Oracle
Windchill (document management system)
FileMaker Pro, Adobe Professional, Embase
Pubmed (Biomedical search engines).
Contact this candidate