Barbara Alspaugh Email and Phone Number
• Extensive experience in highly regulated Biologic Pharmaceutical and Medical Device Industries with 18 years combined Quality Control, Quality Assurance, and Regulatory Affairs experience.• Substantial Regulatory Reporting experience with over 5 years’ experience in Medical Devices with 3500A Regulatory Reporting Submissions, EU and OUS regulatory agencies following ISO9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11), CMDR, and Medical Devices Directive (93/42/EC, 98/79/EC)• Significant Quality Control and Quality Assurance experience with over 10 years’ experience in the Pharmaceutical-Biologics industry following 21CFR 210 and 211• Bachelor of Science in Microbiology with a strong microbiology working knowledge base including site leadership for microbiology issues, aseptic product testing, and aseptic Gowning/Clean Room experience
Depuy Synthes Companies
View- Website:
- thenext.jnjmedtech.com
- Employees:
- 36068
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Regulatory SpecialistDepuy Synthes CompaniesMechanicsburg, Pa, Us
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Regulatory SpecialistDepuy Synthes Companies May 2019 - PresentWest Chester, Pennsylvania, United States• Responsible for supporting Post Market Regulatory Affair activities associated with adverse event and reportable device malfunctions through US, EU, OUS Medical Device Report and Health Authority Vigilance submissions• Prepares and submits Medical Device 3500 A form and/or Health Authority EU Reports within the required agency timelines• Manages and completes responses for FDA and OUS Health Authority Agencies in fulfilling requests for additional information by directly corresponding with agencies to provide further information on device related incidents -
External Quality Batch Release Coordinator, Covid-19The Janssen Pharmaceutical Companies Of Johnson & Johnson Nov 2020 - Apr 2022Grow Project assignment: includes maintaining oversight for all required testing, documentation, deviations, and target release requirements for the COVID-19 vaccine drug product. -
Customer Quality Specialist-RegulatoryDepuy Synthes Companies Jul 2015 - Nov 2018West Chester, Pa• Capture, analyze and process End to End Medical Device Complaints (involving Trauma/Spine/Craniomaxillofacial/Service and Repair) in accordance to US, CAN, EU standards at a high-volume complaint unit following 21CFR 803 and 21CFR 820 regulations • Assess product complaints for adverse events, seriousness, MDR reportability, and categorization• Work in partnership with product development, quality engineers, Local Operating Companies (LOC’s) and other functional experts to ensure understanding and proper investigation of applicable issues.
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Sr. Qa AssociateThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jan 2012 - Jun 2015Malvern, Pa• Supports all areas of Quality to include manufacturing and laboratory compliance, batch record review/product release, and investigation of non-product and product related events utilizing FDA pharmaceutical regulations (21CFR 210, 211)• Person-In-Plant; Partners with manufacturing area to provide on the floor real time support for trouble shooting, decision making, and investigation support of manufacturing activities.• Performs walk-throughs and compliance audits of manufacturing and laboratory areas and processes• QA approver of Event and CAPA record investigations; reviews and support investigations and corrective action plans
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Quality Control Scientist-LeadThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jan 2009 - Dec 2011Malvern, Pa• QC Microbiology delegate for site issues by providing a microbiological perspective to site decisions and investigations; Subject Matter expert for Microbiology issues• Collaborates with Quality Assurance in investigations, deviations, and site issues in supplying microbiological data and expertise• Reviews microbiology data and approves and releases final results for product release
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Quality Control ScientistThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jul 2004 - Dec 2008• Performs all microbiological assays to include: Microbial Identifications using MicroSeq, Kinetic endotoxin LAL testing, Bioburden testing, Biological Indicator testing, environmental monitoring and final product testing. Utilize Vitek and API system microbial identification.
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Biology TechnicianMerck Nov 2002 - Jul 2004West Point, PaControl Monitoring Technician, (January 2004-July 2004)• Main job responsibilities included environmental monitoring of clean rooms and aseptic processing areas, microbial bioburden analysis for water samples, bacterial plate reading and data entry of test results into LIMS based computer systemVirology Technician, (November 2002-January 2004)• Production and research vaccine product Purity and Identity testing using Biotek titration equipment • Virology laboratory experience involved cell culture line and media maintenance, microscopic evaluation of viral cytopathic effects in tissue culture and viral plaque staining techniques
Barbara Alspaugh Education Details
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Microbiology
Frequently Asked Questions about Barbara Alspaugh
What company does Barbara Alspaugh work for?
Barbara Alspaugh works for Depuy Synthes Companies
What is Barbara Alspaugh's role at the current company?
Barbara Alspaugh's current role is Regulatory Specialist.
What schools did Barbara Alspaugh attend?
Barbara Alspaugh attended West Chester University Of Pennsylvania.
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Barbara Alspaugh
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Barbara Alspaugh
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Barbara Alspaugh
Helping Children Become All That They Can Be! Happy! Confident! Respectful!Hampstead, Nc3yahoo.com, ableserve.com, ableinc.net
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