Quality Control Assurance
Resume:
Peter Przywara
Colonia, NJ 07067
********@*****.***
I have had nearly 40 years of quality control involvement and I am highly versed in complaint
management, regulatory compliance and analytical chemistry. My expertise would be quite beneficial to
your business with an extremely high emphasis placed on compliance and due diligence. I am a h ighly
organized and detail oriented professional with in depth knowledge of Pharmaceutical Quality Assurance/
Quality Control compliance including consent decree experience. I have familiarity with incorporating lean
six sigma and continuous improvement practices and principles into daily operations for the organization.
I also demonstrated flexibility in willingness to take on new roles/ positions to support changing business
needs. I have excellent verbal and written communication skills and strong interpersonal skills/ leadership
of diverse professionals including project management.
Experience:
Held positions progressing from laboratory technician, chemist, senior scientist, product complaint
specialist and senior product complaint specialist.
Responsible for the triage, handling and completion of product quality investigations across all
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manufacturing and packaging operations.
Ensured that complaint issues are addressed completely and expeditiously.
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Worked seamlessly with customers, management, manufacturing, packaging, laboratory, SQC as
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well as third party contractors.
I possess a thorough knowledge of c GMP and regulatory compliance criteria.
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I have worked closely with management and quality so that Adverse Event reporting and product
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quality issues are handled properly and with due diligence.
I have prepared Annual Product Reviews (APR’s) and provided the Site Quality Review Boards
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with monthly complaint metrics.
Skills:
Highly skilled in Lean Manufacturing, Cross functional Team Leadership, Root Cause Analysis,
Investigations and CAPAs, Process Improvement, Value Stream Mapping, Kaizen, 5S, Visual
Management. Proficient in Microsoft Word, Project, Excel, Visio, Access, Power Point, Trackwise Change
Control System Knowledge of pharmaceutical regulations and GMP requirements.
Accomplishments/ Miscellaneous:
• Well versed in business principles and have achieved a “Yellow Belt” status.
• Successfully worked through the “consent decree” process and emerged with a more thorough
understanding of the regulatory and compliance processes.
• Member/chairperson of safety committees which yielded the lowest rate of “OSHA reportable”
incidents in company history.
• Member of the drug development team that successfully launched “Claritin D”.
• Received certification for Pharmaceutical Operations and Homeland Security courses completed
through Perdue and Texas A&M respectively.
• Certified “Youth Sports Coach” by Rutgers University.
• Certified EMT D for several decades, and I serve on the Executive Board of Linden Emergency
Medical Services.
Employment:
(Merck & Company from November 2009 to October 2013)
Triaged and assigned complaints to QC Labs, SQC, R&D, Mfg., Pkg., IPL. Legal, Third Party Contractors
for evaluation. Reviewed their investigations and wrote reports. Handled both routine and adverse events
in a due diligent manner. Used deviation management, CAPA, trending, metrics and cross functional
teams to improve product quality. Wrote APR's. I am “Train the Trainer” qualified as well as possessing a
six sigma yellow belt.
(Schering Plough Corporation from March 1976 to November 2009)
Utilized analytical chemistry techniques (gravimetric and titrimetric) on raw materials, API's, LOC's,
tablets, OTC's, Rx, Aerosols and transdermal patches. Familiar with specific gravity, viscosity and
hardness testing, UV/VIS, IR, FTIR, GC, HPLC, AA, TLC, Mass Spec, Particulate Analysis, Dissolution
and Disintegration. I have worked with inhalation aerosols and dry powder inhalers, both rescue inhalers
and metered dose inhalers. Proventil, Asmanex, Vancenase, Advair to name a few. Worked with several
third party manufacturers, 3M, Glaxo and Heist.
Education:
I received an A.A.S. degree in chemical technology from Union County College. I have acquired 125+
college credits from Fairleigh Dickinson and Kean Universities.
References: References can be provided upon request.
Contact this candidate