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Management Quality Assurance

Ambler, Pennsylvania, 19002, United States
January 16, 2018

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SUSAN ZALEWSKI * Ft. Washington, Pa ***** * 267-***-****


GlaxoSmithKlein PHARMACEUTICAL, Collegeville, PA 09/15 - 09/17

Regulatory Affairs Associate, Labeling

Assisted and provided support to Local Operating Companies with management and tracking of GRA

Labeling data in regulatory systems such as Opal and Prion.

Supported LOC colleagues to reduce compliance risks associated with executing labeling revisions.

Interfaced with other GRA or GSK operations functions to ensure consistency of Labeling process /practices.

Compiled and reported information on labeling processes, practices to facilitate GBP across Regions.

Tracked activity and generated reports for management review.

ACCUPAC MANUFACTURING, Lansdale, PA 08/12 – 02/15

Quality Assurance Associate

Created and updated Packaging Batch Records from customer specifications and Bill of Material.

Managed and tracked documentation flow to ensure all timelines were met for production.

Assist/ updated MAR’s (Manufacturing Assay Report) from specifications and certificate of Analysis using AccuTerm.

TEVA PHARMACEUTICAL, North Wales, PA 07/11 - 08/12

Puerto Rico Product Registration Coordinator

Collected, tracked and managed product labeling material, approval letters, and other requisite documentation in response to an internal or external customer inquiry for Puerto Rico Product Registrations.

Interfaced with manufacturing sites to collect documentation.

Scanned, imported, copied and organized tracking process for registrations.

Ensured document integrity and submission readiness for submissions to health authorities.

McNEIL CONSUMER HEALHCARE/J&J, Ft. Washington, PA 02/09 –06/11

Product Labeling Coordinator

Revised SOP’s using Enterprise Document Management system and submitted for approvals for External Manufacturing and Supplier Quality Department.

Used Microsoft Word, Outlook, EDM, PeopleSoft, for day to day job duties.

Provided knowledge in the process for reviewing of components for first time copy samples from EM Packager site.

McNEIL CONSUMER HEALTHCARE/J&J, Ft. Washington, PA 01/05 – 12/08

Regulatory Affairs Associate, Labeling

Proofread many types of labeling (redline, artwork, thermal, inserts) of the labeling lifecycle approval process.

Interacted with other departments (Graphics/R&D/Packaging/QA) for proofreading labeling documents to resolve inconsistencies using Enterprise Document Management system.

Managed and tracked documentation flow for labeling database to ensure all timelines were met.

Assisted in preparing drug listings to the FDA, submission of annual reports, as well as final printed labeling to Benefit Risk Management for the McNeil (OTC) products.

SKILLS - Good working knowledge of MS Excel, Access Database, MS Outlook, MS Word, Oracle.


Bachelor of Applied Science - BASc at Montgomery County Community College, Blue Bell, PA

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