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Click here or scroll down to respond to this candidateCandidate's Name
Langhorne, PA Street Address & Remote PHONE NUMBER AVAILABLE EMAIL AVAILABLE LinkedInSUMMARY AND KEY SKILLSAccomplished, results-driven, and self-initiating Senior Quality Assurance professional with proven success as a Quality Manager and Quality Specialist seeking a position. Remaining adaptable in fast-paced changing circumstances, managing multiple simultaneous objectives, and quickly prioritizing to meet deadlines. Strong interpersonal skills and a positive attitude leading to collaborative working relationships with cross-functional teams, customers, and other stakeholder in remote environments for both domestic and international projects.Regulatory Compliance Code of Federal Regulations Parts 11, 210, 211, 820 SDLC ICH Harmonization EudraLex Annex 11, 15 Leadership Quality Management Systems Continuous Improvements SOP Authoring Excellent Written & Verbal Communication Collaborative Time Management Growth Mindset & Quick Learner Virtual & Remote Highly Organized Technology Savvy Attention to Detail Decisiveness & Critical Thinking MS Office Products Team Player ResourcefulPROFESSIONAL EXPERIENCEQuality Reviewer Contractor- Part Time -Remote 04/2022 PresentUSDM Life Sciences Langhorne, PA Fully Remote, Virtual OfficeCarry responsibility to coordinate multiple quality assurance initiatives including monitoring work and providing insights to improve team performance and support project quality and continuous improvement agendas.Reviewed validation documentation such as Validation Plans, User and Functional Requirements Specifications, Traceability Matrices, and Summary Reports to ensure the documents meet company procedures and regulatory compliance.Instrumental in organizing and maintaining quality assurance procedure documentation and facilitating policy, procedures, and work instructions.Identify training opportunities to drive increased levels of quality through various projects and create and revise SOPs and training materials.Reviewed test procedures and results to verify sound testing methods productive of reliable data and compare products to established specifications and control limits.Senior Specialist IT Quality Assurance- Remote 04/2021 04/2022Organon Pharmaceuticals Lansdale, PA Fully Remote, Virtual OfficeCoordinated and collaborated with internal teams on a daily basis to complete assignments and meet deadlines.Conducted extensive support to multiple domestic and international projects working directly with business process owners, data owners, and technology support, cooperating through excellent working relationships.Managed oversight of GxP (good practice) computerized solutions to ensure compliance with company policies and procedures, and federal and international regulations.Supported the preparation, review, and approval of documentation related to validation and quality operation of computerized systems including core requirements, policies, SOPs, and best practices.Quality Auditor II Medical Imaging- Remote 11/2020 04/2021Bioclinica Princeton, NJ Fully Remote, Virtual OfficeEffectively planned, conducted, and reported detailed GCP vendor audits according to Bioclinica procedures.Monitored and managed the tracking of all audit issues and CAPAs through successful closure.Regularly collaborated with all levels of internal personnel and suppliers and supported both internal and external audits. Performed quality review of documents and case report forms for accuracy.Senior Quality Specialist, Data Integrity 04/2019 07/2020Process Stream at Bristol Myers Squibb Princeton, NJLed and provided oversight to IT quality assurance, maintaining SOPs, and adherence to policies and procedures.Reviewed technical and procedural controls with business owners to determine adherence to data integrity principles. Prepared data integrity gap analyses, remediation plans, and summary reports.Analyzed and audited data and procedures, identified potential data integrity failures, and established appropriate corrective actions.Corporate Computer System Validation Lead 12/2016 10/2018Lannett Pharmaceuticals Philadelphia, PALed and directed validation, quality, and compliance operations for corporate computer systems.Planned and developed procedures for computer system validation and data integrity.Developed validation plans, summary reports, SOPs, and corporate standards.Performed internal audits for multiple manufacturing sites and consulted with project teams on quality issues.Validation SME/CSVSME/Quality Analyst/Project Manager.Consulting Multiple Locations. 07/2013 11/2016Quality Manager- Business & Decision, Wayne, PA 01/2011-07/2013Clinical Quality Manager- Numoda Corporation, Philadelphia, PA 06/2009-12/2010Project Manager- Wyeth Pharmaceuticals, Radnor, PA 01/2002-05/2009TECHNICAL SKILLSProductivity Tools: Microsoft Office (Word, Excel, PowerPoint, Outlook), Microsoft SharePointRemote Collaboration Tools: Zoom, Microsoft TeamsEDUCATIONBachelor of Business Administration Accounting & Business Management Temple University, Philadelphia, PAProject Management Certificate Project Management - Pennsylvania State University, Abington, PA |
