Post Job Free

Resume

Sign in

Business Analyst Document Specialist

Location:
Bethlehem, PA
Posted:
June 07, 2023

Contact this candidate

Resume:

Christopher Patrick Lawlor

Bethlehem PA

adxkj2@r.postjobfree.com

570-***-****

www.linkedin.com/in/christopher-lawlor-28a0275

Summary:

Highly motivated individual with strong problem solving and organizational skills.

Has the ability to work well independently or as part of a team and thrives in a dynamically changing environment.

Solution Consultant, Pre-Sales, Technical Discovery, Client facing, Project Management, SOW creation.

Implementation, RFP, RFI documents analyzed and contracts prepared.

Customer facing presentations utilizing PowerPoint, WebEx, Zoom and customer premise demonstrations. Salesforce utilized.

Years of experience in the IT field presenting solutions to Senior Level Executives.

Intellectual property laws (IP)

IAM experience

SQL, AD experience, Data Analysis, Root cause Analysis

IT Business Management, MS Office 365, MS Project, Document Management

AWS, SSO experience, Salesforce

Technical Writing, guides, SOP (standard operating procedure) SaaS

Customer Service, Documentation, Contracts, Clinical Trials, Deviation Investigations

Professional Experience:

Eisai, Exton, PA Oct 2022-Present

Document Specialist

Routinely interface with electronic Systems (e.g. Veeva, eDocs,Lims, LMS) for Document Control Purposes.

Manage Document Control Work Volume to achieve and maintain Commercial Manufacturing readiness and Business Continuity.

Routinely interface with all site personnel. Interpret and adhere to document control policies, procedures, recommend process improvements to increase efficiencies.

Participate in document control projects and migration activities. Extensive utilization of Veeva Vault. Capa, Deviation investigations

Sanofi Pasteur, Swiftwater, PA Sep 2020-Oct 2022

Document Specialist/Coordinator

Quality Systems group.

Creating and coordinating the Record Retention process of GMP documents for the Antigen Platform. This responsibility includes onsite and offsite record retention.

Creation and control of Production Official Documents and logbooks pre, post and during use. Batch Records reviewed.

Maintaining document control through Production Floor Support, including but not limited to exchanging inactive official copies of documents for active official copies of documents in real time.

Supporting production needs by being responsible for performing administrative tasks such as gathering and preparing documentation to support investigations, operational optimization and/or change controls/CAPAs, Deviations, Principal Investigations. Work with QA.

Ensure cGMP regulations regarding documents, logbooks and Official Documents are always adhered for the Antigen Vaccine Platform. Batch records reviewed and updated.

Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization

Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies

Sanofi, Swiftwater, PA May 2020-Sept. 2020

Production Tech

Work with vaccines with Dividella, Weiler, Cormia machines

Labeling

Complete and sign-off corresponding documentation

Documentation review, cGMP

Cancer Patient Advocacy, PA, NJ

Patient Advocate, Document Specialist Apr 2019 – Apr 2020

Working with and supporting patients as they go through chemotherapy and alternative treatments.

Prepare documentation for hospitals, doctors and insurance companies.

Research and locate clinical trials for patients.

Analyze and review contracts for clinical trials.

Follow up and review of test results throughout treatments and clinical trials.

Work with hospitals organizing treatments and patient requests

Prepare patients for next steps in treatments including Palliative services

Utilize Zoom, Webex, videoconferencing

Pfizer Corporation, New York, NY 2018 - 2019

Senior Business Analyst, Project Manager

Collect business requirements (process, outcomes, use cases, etc.…) from Stakeholders.

Run market research to help identifying the vendors (3rd party) that would be candidates to provide this type of technology, A global Cloud based Anti-Counterfeiting platform.

Create the RFP process and support the decision process, Technical writing, root cause analysis

PfizerSDLC process included distinct stages, including planning, analysis, design, building, testing, deployment and maintenance. Contract analysis, review and selection of 3rd party vendors

Documentation and coordination of projects, SDLC, Agile, Waterfall Methodologies, Tableau.

Worked on Global projects, Communication channels between stakeholders, vendors customers, cGMP

Worked with SaaS and Design Thinking.

International Anti-Counterfeiting Coalition (IACC), Washington DC, East Stroudsburg, PA 2016 –2018

Project Manager/IAM Business Analyst, Program Manager

Gather Technical and business requirements from major brands.

Support major brands in their anti-counterfeiting efforts and IP (Intellectual Property)

Investigate origins of counterfeiting and corruption

Monitoring and controlling project activities to keep critical path and major milestones

Create reports from various databases utilizing SQL, Access, excel, AD

CRM experience

Developed and updated Identity and Access Management (IAM) process documentation for access reviews.

Enforced access management using IBM Security Identity Manager and OpenIAM.

Technical Writing, guides, SOP (standard operating procedure)

AWS and SSO experience, Webex, videoconferencing

STRATEGIC MICRO SYSTEMS- Parsippany, NJ 2015 –2016

Project Manager/Business Analyst/Sales

Enhanced IT infrastructure and Security for clients through offerings of Cloud Back up Disaster Recovery solutions.

Performing all project management standard tasks that follow the PMO’s methodologies

Create proposals, SOW’s to meet customer needs, created and delivered customized contracts.

Utilization of Salesforce to track milestones and create reports for clients and stakeholders.

Pre-sales, sales

RICOH CORPORATION- W. Caldwell, NJ 2012 –2015

Business Analyst, Solutions Consultant

Develop creative business strategies for customers and prospects to improve their processes and document management workflows using systems, software and services. Salesforce exclusively utilized.

IT expert in various solutions for small business including phone systems, firewall, Disaster Recovery/Back up, Videoconferencing, Portable Video Conferencing units, Interactive Whiteboards, Cloud services, support contracts, various document management services. Support 3 sales teams consisting of 24 account executives. Write proposals and scopes of work. Prepared pricing and solutions to various sized businesses. SOW’s created and reviewed.

Salesforce, CRM experience, Share point. Docuware, Kofax workflow management

Agile, Waterfall methodology utilized.

Created contracts, including pricing, scope of work and various clauses (milestones met, termination, etc.)

Partnered with and managed vendors and other third parties to offer products and services.

Sales, pre-sales, post sales

CLC COMMUNICATIONS- New York, New York 1999 – 2012

Project Manager, IT Auditor/Sales/IAM Analyst

Responsible for the planning, execution, and management of audits and reviews of complex, multinational, publicly traded and privately held companies. Presenting Executives with solutions and documentation.

Experienced with Compliance Regulations, SOX, HIPAA, FISMA

Worked with Financial industry, Brokerage firms, banks, Insurance firms

Investigate origins of errors in billing and pricing

CRM and IAM experience.

Enforced access management using IBM Security Identity Manager and OpenIAM

Governance, Risk, Compliance

Sales, pre and post sales

Education:

Bachelor of Science - Media, Communications and Technology

East Stroudsburg University of Pennsylvania



Contact this candidate