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Business Process Analyst Resume

Princeton, NJ

PROFILE OF QUALIFICATIONS

  • 15+ years of professional experience in Quality and Information Mgmt & Science for Pharmaceutical, Life Science, and Biotech industries
  • Presentation and procedural documentation development facilitation skills
  • Strong project management, leadership, team building and organizational skills
  • Demonstrate commitment to cooperation, customer service, and delivering results
  • Strong expertise in business process improvement, mapping, modeling, and analysis at all levels (enterprise, divisional and department)
  • Demonstrate a high level of planning, which results in accurate project and action planning
  • Strong communication skills; demonstrate strong attention to details
  • Demonstrate ability to quickly learn new IM systems and to train and support others on how to use them
  • Proficient in interviewing subject matter experts (SMEs)
  • Strong understanding of SDLC and 21 CFR 11, Quality Management and GxP (21 CFR 210, 211, and 820)
  • Strong understanding of ICH guidelines and SOX compliance
  • Customer relationship management (CRM) business solutions definition (logistics, sales, contracts, support, and call centers)
  • Strong expertise and proven track record of procedural and document writing including compliance related policies, directives and SOPs
  • Experienced in working with international markets

PROFESSIONAL EXPERIENCE

Confidential, (Princeton, NJ)
01/2009 03/2010
Manager, Business Process, Compliance

  • Serves in a compliance capacity and plays a key role as Chair of the Policies & Procedures Committee
  • Manages and oversees controlled compliance documents policies and procedures, which include Policies, SOPs and Working Practices
  • Oversees processes to ensure that company compliance documents fulfill regulatory compliance requirements as well as the business goal requirements
  • Introduces and drives compliance best practices to establish compliance controls
  • Investigates and resolves compliance issues to ensure compliance with cGxP (QSR and ISO) and safety policies
  • Manages all process documentation, internal as well as external projects working with internal Key Stakeholders and external consultants
  • Interacts with all levels of the organization
  • Provides expertise in process analysis, mapping, and procedural writing to the user community to improve compliance and/or remediate process gaps
  • Works with the senior management in the implementation, editing, and follow-up duties for process efficiency and regulatory compliance requirements

Confidential, (Princeton, NJ)
02/2004 01/2009
Business Process Analyst/ Sr. Technical Writer

  • Managed a group of contractors
  • Managed procedural document development life cycle on a daily basis includingbusiness process analysis during document development (process mapping) to assure compliance with regulations and corporate policies
  • Managed multiple complex projects; interfaced with Corporate Compliance, Financial Shared Services, Information Security, Technical Operations, and IM management
  • Managed project deliverables and risks; wrote test scripts in support of validation activities; maintains traceability matrix; facilitated meetings
  • Provided quality and compliance support to stakeholders to ensure that government regulations and IM quality standards are followed
  • Provided QA and compliance expertise, and supported for internal clients and divisional teams to identify supporting documentation
  • Provided formal trainingto contractors in document development process, quality review and compliance
  • Interacted with local/regional departments/functions and provided quality support for global projects
  • Followed IM best practices and collaborated with other departments to establish practices based on the business processes functional area
  • Served as first point of contact on documentation creation questions

10/2003 12/2003
Quality Management Document Analyst

  • Assured document adherence to corporate policies and procedures
  • Provided expertise within departments to develop Policies, Directives, Standards, SOPs, and Work Instructions beginning from requests for development/change and ending with document publishing
  • Communicated with and provided guidance to stakeholders to define and document procedural documents to meet the Quality System requirements and FDA expectations

Confidential, 05/2003 11/2003 ,Lansdale, PA
Business Analyst,

Defined objectives and requirements for Sales and Marketing related systems
Performed process mapping, gap analysis, modeling and re-engineering between Field Data Distribution Services (FDDS) and QA/Integration departments; developed and revised Quality Management SOPs, standards, guidelines, and other procedural documents
Conducted personal interviewing (SME - middle and senior management, field reps, etc.)
Provided training and mentoring to team members; participated as an active member of cross-functional teams and task forces
Participated in business related tasks to improve quality documentation processes in compliance with Merck standards
Prepared presentations and facilitated meetings

02/2002 02/2003 Confidential, Rahway, NJ
Business Analyst

Worked on remediation of clinical trial system processes to meet 21 CFR 11 quality & validation audits
In-house created clinical trial system (CRISP) worked in both on-line and off-line (remote) modes. Data was entered either directly to global database or to remote data collectors (lap-tops) and then loaded into global database using data transmission and synchronization tool
Provided QA support and expertise in validation documentation review and SOP writing to ensure GxP compliance
Performed process and data modeling (Visio)
Interacted with all key QA and Application Engineering personnel

Confidential, (New Brunswick, NJ) 01/2001 12/2001
Business Analyst
Worked on Data Repository system for IND/NDA analytical documentation submission

  • Worked with AR&D, Informatics, and Tech Ops teams to investigate their documentation transfer processes during IND/NDA submissions
  • Mapped and documented analytical methods and technical transfer processes modifications
  • Acted as primary liaison between functional groups, team managers and stakeholders
  • Created process models; performed business event analysis; use cases analysis; change management; revised SOPs; prepared presentations Technical environment included SQLLIMS, Documentum docbase, Oracle, and Windows NT/2000.

Confidential, (Mt. Laurel, NJ) 01/1999 - 12/2000
Manager/Business Analyst for Pharmaceutical Practice
CRM products (package) implementation/customization and process mapping/modeling for Logistics, Contracts, Sales, and Call Center modules:

  • Defined CRM package implementation (Clarify) objectives, scope, deliverables, timelines, and resources
  • Acted as SME with regard to gathering business requirements within the scope of CRM projects
  • Identified and resolved issues with clients to keep projects on schedule
  • Mapped and documented business processes (SOPs) and created process models (Visio)
  • Performed end users training on a newly developed functionality following processes outlined in SOPs
  • Coordinated efforts with delivery and development teams

EDUCATION

M.S. - Electrical Engineering
B.S. - Mechanical Engineering

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