6 Fayette Place • Fair Lawn, NJ 07410 • (201) 873-1833 •
Nancy J. Sperling Page Two
 Coordinating compliance training as required with Operations.
 Attending local Site Quality ...
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NancySperling resumeManufacturing&Supplier

Published on: Mar 3, 2016

Transcripts - NancySperling resumeManufacturing&Supplier

  • 1. NANCY J. SPERLING 6 Fayette Place • Fair Lawn, NJ 07410 • (201) 873-1833 • PROFILE & SKILLS Quality Assurance and regulatory compliance professional with more than 20 years of experience in cGxP (cGMP, cGCP and cGLP) within the following industries: Pharmaceuticals, Biological, Medical Devices, Clinical and Consumer Health Products. Known for being very meticulous, paying attention to even the smallest detail, ensuring compliance of the quality systems which I have supported.  Excel in quality system responsibilities which include successful cGMP Internal and Supplier quality auditing and management of quality systems (notebooks, batch records, instrument logbooks, etc.) training, SOP, protocol and validation preparation and review, change control review, deviation review and CAPA support as it pertains to manufacturing, clinical, laboratory, warehouse, sample management, fulfillment and call center activities.  Record of achievement in leading and managing cross-functional teams comprised of internal staff, third party vendors (CROs and CMOs) and regulatory authorities for analytical method transfer, PAI readiness in preparation for agency audits and Compendia Affairs activities.  Complete knowledge and application of: 21 CFR 600 series, 21CFR210, 21CFR211, 21CFR820, ISO9001, ISO13485, EU regulations and ICH guidelines. Contributed to CMC section of filing.  Excellent oral (including formal presentations) and written communication (report writing expertise), project management and computer/database management skills (Microsoft Office expertise includes: Word, Excel, PowerPoint and Access). Extensive knowledge of medical and scientific terminology; works successfully within a team environment and as an individual contributor. SKILLS  Certified Six Sigma Green Belt (CSSGB)  Experienced ASQ CQA and Lead Auditor  Skilled and knowledgeable in : Food and Drug Law, Quality Audit, Good Laboratory Practice, Drug Development, Good Clinical Practices, Bioethics, Post-Approval Changes, Project Management, Advanced GMPs, Global Excipient Regulations, IND/NDA Submissions, Global Medical Device Regulations. EMPLOYMENT Novartis (East Hanover) Sept 2014-May 2015 Senior Technical /Medical Writer (Consultant) Ensured compliance oversight of Testing Monograph up-dates, Product Release Specifications, and Analytical Method changes.  Wrote, edited and facilitated approvals of Standard Operating Procedures, Templates, Protocols and Reports for External Supply Operations (ESO), using tools such as TEDI, Novstyle and Dragon.  Participated in cross-functional teams to ensure the objectives of ESO were met and that all of the Testing Monographs are properly maintained.  Ensured proper supply chain information management and batch release utilizing SAP.  Managed change and tracked teams and projects through the use of AQWA and Agile. Students 2 Science (East Hanover NJ) April 2014-Ongoing Mentor and Assistant Lab Instructor  Volunteer as Instructor at Students 2 Science, a non-profit corporation operating a modern analytical laboratory for the purpose of hosting New Jersey Middle and High School Students and inspiring students to pursue career opportunities in Science, Technology, Engineering and Mathematics fields.  Engaged in method development of virtual laboratory experiments that are brought directly to schools ORTHO-CLINICAL DIAGNOSTICS (OCD) Raritan, NJ February 2013- April 2014 Staff Compliance Engineer Managed and maintained a robust compliance program for in vitro diagnostic products manufactured by OCD. Ensured compliance in two areas: Transfusion Medicine which is involved in screening human blood, and Clinical Laboratories, which performs a variety of chemical and immunodiagnostic testing, which was accomplished by:  Performing internal audits as per schedule and ensuring adequate corrective action plans, through tracking and trending metrics to address audit observations.  Partnering with various Compliance teams, monitoring and ensuring effectiveness of quality program and that domestic, international policies and regulations and J&J corporate requirements were being followed by these groups.
  • 2. Nancy J. Sperling Page Two  Coordinating compliance training as required with Operations.  Attending local Site Quality Issue Review and Site Quality Review Board meetings as compliance oversight and approver per assigned Value Stream (product line) and providing updates on quality and compliance metrics. MySTRO a Division of InVentiv Health, Inc., Totowa, NJ January 2012-January 2013 QA Compliance Manager (Consultant) Supported Quality Assurance functions of MySTRO, a leading provider of multi-channel marketing, providing healthcare clients with seamless sales force support, telephone and remote personal selling, print and direct mail, warehousing, fulfillment, data management services, sample accountability, regulatorty and PDMA compliance services. Mitigated risks and ensured company-wide compliance to DEA, PDMA, cGMP regulations achieved through:  Managed documentation and ensured Change Control, Incident Investigation, Training and Corporate Policies were being followed and were being updated as needed.  Provided oversight on the creation, maintenance and implementation of SOPs for Client Services, Fulfillment, Call Center, Warehouse, Sample Management, It and Regulatory.  Maintained internal and external compliance with audit program and manages site inspections by Clients, Federal and International Regulatory agencies.  Partnered with department managers to address quality, distribution and fulfillment issues. Johnson and Johnson (RPS), Morris Plains, NJ January 2011- January 2012 Quality Assurance Associate Manager-GMP, Quality Management (Consultant) Managed and maintained all quality systems for analytical and microbiological laboratories used to test consumer health products at J&J. This work was performed as an employee of Research Pharmaceutical Service (RPS), a CRO, and was accomplished through:  Conducted and managed periodic audits of APD internal systems, departments and vendors as required by internal audit schedule and facilitated and managed timely completion of remediation, corrective and preventive action (CAPA), investigation and deviation and change control activities tracking through trend analysis.  Tracked all quality lifecycles and perform periodic trend analysis and report metrics to Quality Management as necessary.  Facilitated the creation, coordinated the training activities and reviewed applicable Standard Operating Procedures (SOP) to support the quality function and APD activities which were aligned with FDA regulations and client requirements.  Provided guidance to APD employees in relation to regulatory topics and trends. PFIZER INC. (LEGACY WYETH), Pearl River, NY June 1992-July 2010 Quality and Regulatory Compliance Professional (2000 – 2010) Oversaw compliance, quality, data integrity, method validation, technical transfers to and participated in quality activities supporting Global Manufacturing at Wyeth, a pharmaceutical company, to ensure release of clinical and commercial batches.  Managed transfer of analytical chemistry methods between labs, drawing on experience as chemist and biochemist and expertise in Chemistry Manufacturing and Controls to ensure cGMP compliance of numerous analytical laboratories at domestic and foreign sites.  Drove preparations that resulted in highly favorable outcomes of all PAI audits (20) by organizing and managing pre-audits; among other strategies, used Web-based reporting tool Brio to effectively store and promptly retrieve archived documents, pre-audited notebooks and analytical data to ensure information integrity and reconcile data with data in LIMS, and independently verified IQ/OQ/PQ of laboratory equipment. Analytical Chemist II (1995-2000) and Biologist (1992-1995) Developed and validated analytical methods for small and large molecules using various techniques and instrumentation. EDUCATION MS, Quality Assurance and Regulatory Affairs, Temple University, Philadelphia, PA MS, Toxicology, St. John’s University, Jamaica, NY BS, Animal Science, Pre-Veterinary Medicine, Iowa State University, Ames, IA AFFILIATIONS  New Jersey Pharmaceutical Quality Control Association  American Society for Quality  Society of Toxicology  American Association of Laboratory Animal Science  American Chemical Society  ChemPharma®  Fair Lawn, NJ, Environmental Commission, Green Team and Garden Committee

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