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Work Background
Johnson & Johnson Innovative MedicineTeam Lead, Product Quality Management
Jul. 2024Raritan, NJEnd-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products. Responsible for product quality related activities with a specific expertise in stability Lead and support cross functional teams with a focus on stability program management Manage & Mentor team of Product Quality Specialists
Johnson & Johnson VisionProgram Manager (GROW Rotation)
Jul. 2021 - Jul. 2022• Develop and implement a Quality Management System strategy for product portfolios, site and/or production lines aligned with the business G&Os. • Partner with other J&J Vison sites to ensure that franchise Quality System procedures are compliant, effective, and efficient when deployed in these related units. Utilize stakeholder inputs to ensure that the overall objectives are achieved. • Provide support for FDA and other governmental or ISO Notified Body inspections conducted at JJV locations. • Represent JJV Quality and Regulatory Compliance Department on various internal teams and working groups. • Transfer of Product Stability Program of J&J Surgical Vision to J&J Vision Care organization
The Janssen Pharmaceutical Companies of Johnson & JohnsonProduct Quality Specialist
Mar. 2018 - Oct. 2024Raritan, NJResponsibility for product quality related activities (pre/post launch) with a specific expertise in stability. Accountable for all stability related activities of commercialized products including change management & study management Carries out stability management activities: commentary and finalization of reports, data interpretation, providing specific technical knowledge and skills. Evaluates stability data and makes qualified judgements and recommendations expressed in commentaries on reports and data tables.
The Janssen Pharmaceutical Companies of Johnson & JohnsonStability Integrator/Stability Owner
Sep. 2016 - Mar. 2018Raritan, New Jersey, United States-Responsible to evaluate and propose stability requirements for New Product Introductions (NPIs) or Post-approval Changes -Accountable for require stability’s method transfer including protocols and reports generation and ensure activities related are appropriate executed by transferring and receiving laboratories. -Responsible to manage product situations related to stability program and lead for escalating stability related issues -Make Quality decisions related to stability management. -Makes decisions on behalf of stability related to stability and method transfer projects
Johnson & Johnson Consumer HealthStability Specialist
Oct. 2014 - Sep. 2016Fort Washington, PAOversee EM Stability program to maintain consistency and adherence to stability standards and systems Maintain a list of all ongoing stability studies at external stability testing sites Review and approve stability plans, protocols, and final technical reports Review on-going stability data generated Perform statistical analysis of stability data Maintain required stability program metrics Collaborate with Home Office, Research & Development, and site QA Stability personnel to manage and improve stability processes Act as analytical subject matter expert (SME) for Out of Specification/Out of Trend investigations Provide guidance in resolving stability issues and compliance concerns
McNeil Consumer HealthcareSenior Scientist
Jan. 2012 - Oct. 2014Fort Washington, PAResponsibilities include: Manage testing, review, and approval of analytical data to support the reference standard program (USP/Ph Eur. Pharmacopeia) Supervise direct reports by fostering an independent working environment with an emphasis on quality and compliance Author and Review Standard Operating Procedures Developed and implemented new system for data and inventory management
McNeil Consumer HealthcareSupervisor (Kelly Management Services)
Feb. 2006 - Jan. 2012Fort Washington, PADec 2009 - Jan 2012 Managed team of auditors performing gap analyses to determine compliance to in-house SOP’s, GxP and ICH requirement Generated detailed summary reports of audit findings Coordinated manufacturing of placebos, and distribution of placebos and raw materials between international sites Feb 2006 - Dec 2009 Organized analytical testing to support product launches Authored cGMP documents to support product shelf life Review of laboratory notebooks, instrument data, and LIMS entries for technical accuracy and compliance with cGMP requirements Served as SME for new LIMS system Served as Trainer all incoming new hires
McNeil Consumer HealthcareResearch Analyst (Kelly Scientific Staffing)
Jul. 2004 - Feb. 2006Testing OTC products for McNeil Consumer Healthcare.
Kelly | Scientific Resources (at Wyeth)QC Analyst
Nov. 2003 - May. 2004West Chester, PATested in-process bulk and finished product via HPLC
Siemens Medical SolutionsQC Technician
Sep. 2002 - Oct. 2003Testing in-process samples for production.
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