Beth Sowden Wise Email and Phone Number
Beth Sowden Wise work email
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Beth Sowden Wise personal email
A dedicated, highly organized professional with over 18 years of experience in the medical device/pharmaceutical industries. I have acquired expertise in all aspects of document control and ensuring compliance with FDA/ISO/GMP standards, regulations, and procedures. With excellent oral and written communication skills, I thrive on new challenges and opportunities. I am highly motivated, goal-oriented, and results driven and strive to improve quality and efficiency. I am a strong team player while also able to work well independently. Some of my strengths include solid interpersonal skills, excellent computer skills, critical thinking and analysis, and an ability to learn new concepts quickly. Specialties: Systems change control-creating, editing, and proofreading documents, Quality System improvements, technical writing and editing, project management, project coordination, data analysis, database management, and GMP support.
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Regulatory Affairs - Operations AssociateW. L. Gore & Associates Nov 2018 - PresentNewark, Delaware, Us
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Change AnalystW. L. Gore & Associates Jan 2017 - Oct 2018Newark, Delaware, UsManage all facets of document management and change control processes to ensure compliance with all internal procedures and regulatory requirements within the W.L. Gore Medical Products Division.
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Specialist, Quality SystemsWest Pharmaceutical Services Apr 2016 - Dec 2016Exton, Pa, UsSupported and managed the Pharmaceutical Delivery System (PDS) Quality Assurance document management and training systems at the Corporate Headquarters in Exton, PA. Maintained and implemented changes to those systems to meet internal/external customer needs and all applicable regulatory requirements. Managed the issuance and controlled distribution of final product specifications, drawings, and documents to PDS customers. Coordinated training for all Exton employees. -
Document ControllerDsm Biomedical/Kensey Nash May 2012 - Apr 2016Ensured compliance of DSM Biomedical documentation systems with all Quality/GMP/ ISO/FDA standards and regulations. Managed and maintained multiple change/inventory control systems including: Windchill PLM, Pro/lntralink, Manuscript, Agile, JD Edwards and Oracle. Control electronic imaging, archiving, and record retention of all quality system records.
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Document Control AdministratorSynthes May 2005 - May 2011Raynham, Ma, UsAssured compliance of Synthes/Norian documentation system with all Quality/GMP/ ISO/FDA standards and regulations. Managed and maintained multiple change/inventory control systems including: Windchill PLM, Pro/lntralink, Manuscript, Agile, and JD Edwards. Responsible for electronic archiving, imaging, archiving, and record retention of all quality system records. Successfully migrated all acquired historical Norian documentation to the parent company, Synthes.
Beth Sowden Wise Skills
Beth Sowden Wise Education Details
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University Of PennsylvaniaMaster Of Fine Arts -
University Of DelawareBachelor Of Arts (Ba)
Frequently Asked Questions about Beth Sowden Wise
What company does Beth Sowden Wise work for?
Beth Sowden Wise works for W. L. Gore & Associates
What is Beth Sowden Wise's role at the current company?
Beth Sowden Wise's current role is Regulatory Affairs - Regulatory Operations W. L. Gore & Associates.
What is Beth Sowden Wise's email address?
Beth Sowden Wise's email address is so****@****hes.com
What schools did Beth Sowden Wise attend?
Beth Sowden Wise attended University Of Pennsylvania, University Of Delaware.
What skills is Beth Sowden Wise known for?
Beth Sowden Wise has skills like Medical Devices, Change Control, Software Documentation, Gmp, Data Management, Iso, Sop, Quality Control, Quality System.
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