JENNIFER FINN

860-***-****

ac0g1z@r.postjobfree.com

SUMMARY

A solution-focused professional with expertise in the Medical Device, Pharmaceutical and Biotechnology fields. Analytically-oriented with an impressive background and thorough understanding of Current Good Manufacturing Practices (cGMPs) systems. Diligent, persistent and committed to excellence in all activities with enthusiasm for projects.

PROFESSIONAL SKILLS

Thorough understanding of cGMP systems and processes, and International Council for Harmonisation (ICH) Guidelines, and ISO requirements

Extensive experience working in Systems, Applications & Products (SAP) an enterprise resources system (ERP), Laboratory Information Management System (LIMS)

Excellent collaboration skills working cross-functionally among internal and external stakeholders

Food and Drug Administration (FDA) inspections

Proficient in managing multiple projects

Ability to analyze data and prepare summaries

EXPERIENCE

Full time homemaker and community volunteer (2012 – present)

PHILIPS ELECTRONICS

Senior Quality Analyst (2008 – 2011)

Responsible for rigorous analytics applied to the assessment of all components of quality complaints for site medical devices to ensure FDA, ISO and other regulatory bodies safety requirements met

Assessed performance against internal/external benchmarks, partnering with customers to ensure continuous performance gains were delivered with compliance and strong end-user focus

Partnered with interdependent departments (i.e., engineering, regulatory affairs, marketing) to ensure that meaningful and effective Quality data strategy were in place and available for required analyses

Accountable for providing meaningful and effective Quality data strategy to senior management and Original Equipment Manufacturer (OEM) customers

Performed internal quality audits

Coordinated customer complaints data for review to develop, recommend and monitor corrective and preventive actions (CAPA)

Served as the designated Quality Complaints representative for interfacing with regulatory inspectors from the FDA and other global regulatory bodies that inspected the Connecticut site

GLAXOSMITHKLINE

Quality Assurance Compliance Specialist (2006 – 2008)

Responsible for Annual Product Review (APR) reporting for all site products (onsite manufacturing and CMO) to verify consistency of the manufacturing process, assess trends, determine the need for change(s) in drug product specifications, control procedures- this included statistical analysis of manufacturing, stability, microbiology and analytical data, and review of validation, recalls, customer complaints, adverse drug events (AEs), and regulatory notices to identify the need(s) for revalidation

Ensured continuous improvement of the Quality Management System for a cGMP compliant and effective Quality System infrastructure

Coordinated, supported and proactively maintained cGMP compliant and scientifically sound Standard Operating Procedures (SOPs), Work Instructions (WIs) and related training in collaboration with subject matter experts

Led Supplier Scorecard initiative, coordinating efforts of cross functional Compliance and technical resources to support Materials Management and Quality Auditing needs for proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials

Championed development of the Reduced Testing Program, ensuring compliance with cGMPs while effectively decreasing cycle time, reducing retest frequency due to vendor reliability issues (vendor certification), to ensure overall improved supplier management

Facilitated required documents for Regulatory Affairs (Investigational New Drug (IND), New Drug Application (NDA) & Abbreviated New Drug Application (ANDA)), Quality Assurance, Audit staff and other stakeholders

Responsible for adhering to Quality Assurance regulations of the FDA and other global regulatory bodies that inspected the New York site

Managed Key Process Indicators (KPIs) to ensure delivery against strategic organizational goals, costs and quality objectives; reporting impact/value assessments of performance

Provided compliance guidance and support to production and laboratory teams to meet quality standards

Monitored industry-wide FDA Warning Letters and compliance updates as part of continued efforts to remain vigilant with respect to current industry standards

LAW FIRM

Paralegal (2004 – 2006)

Worked directly with attorney on multiple aspects of client files for real estate closings, including contract preparation

Maintained database and files, and performed other office administrative tasks

Prepared real estate closings documents

Tracked all aspects of in-process real estate files

Ensured attorney and clients were informed of the file status, as well as important dates

CURAGEN CORPORATION

Senior Research Associate (1998 – 2003)

Performed genomic research, including cloning, high throughput sequencing and data analysis, in support of Pharmacogenomics, the Human Genome Project and Genetically Modified Organisms (GMOs)

Coordinated, supported and proactively maintained Current Good Laboratory Practices (cGLPs) compliant documents and related training

Responsible for routine quality data analytics and results communication applied to cloning and high throughput sequencing research for customer reporting

Performed protein profiling using high resolution electrophoresis for selection of differentially expressed proteins in support of proteomics

EDUCATION

ROGER WILLIAMS UNIVERSITY

Bachelor of Science, Biology 1998

TECHNICAL SKILLS

Microsoft Word, Excel, Word, Visio, PowerPoint, Lotus Notes, Access, LIMS, SAP

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