OBJECTIVE:
Pharma Technical Professional - performs technical writing and design skill developmental and training initiatives. Have demonstrated and proven work experiences and accomplishments within varied industries. Pharmaceuticals, Finance and Auditing, Artwork and Labeling Deployment, Research and Development, Technical Training and QA/QC, Regulatory Affairs data recording, Validations, storage and documentation retrieval, and FDA/EPA conformance, Global GMP’s practices, pharmaceutical e-learning, web-ex training delivery methodology. Responsibilities also include implementation of varied instructional design abilities in technical documentation, user-end software development and design for asynchronous and synchronous e-learning training technique.

SUMMARY OVERVIEW:

• Create, organize and deliver new training programs and materials for R&D/Plant Operations/HR
• Assist with the review process and procedures for revising SOP/Document Control
• Assist with mapping Process Development
• Assist with Scope Process Analysis and Cause and Effect Problem Solving
• Develop measure efficiency and effectiveness and plan implementation
• Review current standards to bring into compliance with industry standards
• Meet new objectives for CMC
• Assist in building a Quality Systems DMAIC Mapping Process
• Assist in the Solution “TO BE” FMEA Validation Process
• Assist employee/stakeholders with annual FDA required course annual certifications and validations.
• Review and evaluate apprenticeship standards for manufacturing and production batch Record and Tolerance for QA/QC testing.
• Maintain and create new and revised SOP’s/ISO guidance document numbers EPA and FDA for non-conformance issues.
• Maintain and compose Out-of-Specification Reports, Investigation Reporting and re-assignment, Corrective Action/Prevention and Action Reporting.

EDUCATION/CURRICULUM VITAE:
Masters of Education
Bachelor Science

PROFESSIONAL EXPERIENCE:
Confidential,PA 05/2011 – 12/2011
Best Practices -Data Pack Commissioning & Qualifications Professional, (Consultant)
Assist Commissioning, Validations and Qualification activities in support of a renovation project of an existing flu manufacturing building.

• Provide guidance document technical writing – protocols, reports, and other documents required by the project.
• Provide field execution support, coverage, and activities for manufacturing personnel.
• Safety Trainer all levels of personnel in manufacturing and production.
• Assist with Deviations, Change Control Routing and documentation activities.
• Assist with safety walk-through of production and manufacturing site and equipment validation execution.
• Create and work through mechanical execution documentation issues.
• Ensure Traceability of Functional Requirements through review and of Mechanical Completion designs and equipment testing.
• Assisted Validations, QA and Execution Team professionals to ensure that the deliverables meet the executable requirements.
• Coordinate the review process and ensure that all feedback is addressed.

Confidential,PA 10/2010 – 05/2011
R&D Plant Operations Training and Development Manager (Consultant)

• Presented documentation for new hires classroom and on-site performance and demonstration training.
• Developed and reviewed QA testing and record and tolerances evaluation procedures and processes
• Provided OSHA Safety plant and Chemical handling and mixing trainings and assessments
• Provided trainings for Di water and wastewater processes in compliance with City Ordinances
• Demonstrated safety chemical PPE training for HAZMAT regulations and guidelines
• Data Recording and Tolerances on-the-job trainings for Quality Assurance guidance documentation
• Prepared module learning objectives, data, templates, program testing, results data and reports
• Created and processes trainee performance certifications per FDA /EPA regulations

Confidential,PA 06/2008 - 08/2010
Technical Writer (Consultant)

• Design visual instructional presentations, reports and webpage design layouts.
• Revise or create Client business plan layouts to design technical and Instructional manuals.
• Provide research and business portfolios for marketing trends.
• Prepare presentations of market studies and analysis.
• Develop and implement quick reference guides and employee toolkits.
• Consult and develop perspective new business planning, market research and product analysis.

Confidential,PA
Instructional Design-Technical Writer (Consultant) 09/2007 – 03/2008

• Created technical text for Bio Pharma and EMEA, PDM, CCTRL presentations
• Wrote, maintained and designed uploads of lifecycle flowcharts, process, stakeholders toolkits and dashboards.
• Created instructional documents, Artwork and Labeling designs /C- CTRL for ELTAR, ELIS, PDM, and Meta Storm
• Wrote and revised technical documents to meet BoH compliance and SOP’s and GMP manuals
• Created and processed TPAR training reports and product conformance.
• Maintained validation documents via utilizing Documentum, Trackwise and e-Room databases.
• Complied and processed Standard Operating Procedures (SOP’s) per EMEA and FDA Rules and Regulations from Europe (RoW) OSHA safety processes and US Federal Government Agencies compliance.
• Prepared presentations and maintained SAP Financial systems technical and end-user manuals, SAP source data functions, storage, retrieval and extractions.

Confidential,NJ 05/2005 – 04/2007
Corporate Financial Associate (Division Closed)

• Revised various technical, written and (SEC) Securities Exchange Commission quarterly filings.
• Provided internet technical support and due diligence process
• Created, revised 10-Q, 10-K, and 8-K Sec quarterly filings in concert with CEO and Controller.
• Prepared, revised legal documents regarding Sarbanes Oxley (SOX) compliances and audits.
• Monitored and prepared accounts receivable payment and balance documents
• Prepared weekly focus meetings and conference material.
• Prepared presentations and maintained SAP Financial systems end-user manuals.
• Input SAP source data functions, storage, retrieval and extractions.

Confidential,PA 11/2005 – 05/2006
Metrology – QA - Calibration (Consultant)

• Provided revision and creation from referenced material for GMP’s and FDA guidelines.
• Developed training curriculum for Human Resources for Metrology presentations.
• Maintained validations for conformance and non-conformance procedures and policies manuals.
• Complied with SOP’s Standard Operating Procedure per FDA regulations.
• Maintained Metrology completed instrument calibrations documentation.
• Reserved conference rooms and audio equipment
• Provided technical instruction training material referencing eRoom, Trackwise for FDA GMP docs.
• Developed and created technical material for employee dashboard accessibility.
• Assisted and trained SAP with computer-based trainings.
• Updated and maintained Metrology Metric System Safety and Quality Performance Charts.

Confidential,NJ 08/2005 – 11/2005
Central Speaker Specialist (Consultant)

• Supervised new student technical learning program curricula.
• Coordinated and created synchronous training material and testing.
• Identified and wrote document standardized speaker management processes.
• Assisted Regional Scientist and Medical Professionals compliance and registration sessions.
• Managed a web based application to support the RSD with speaker management initiatives.
• Provided and managed all speaker training initiatives and activities.
• Ensured all corporate standards of excellence and compliance.
• Certified Medical Professionals through database file management for product conferences.
• Defined and tracked brand product speakers for scheduled seminars and web-cast conferences.
• Reviewed and monitored status of speaker nomination training, and approve speaker nominees

Confidential,PA 03/2002 – 08/2005
Academic Advisor, Admissions Assistant Director for Recruitment

• Promoted university to prospective students and parents.
• Directed the admissions process for enrollment and maintained admission statistics.
• Assisted and trained office personnel in SAP purchasing order systems and maintenance.
• Coordinated recruitment efforts and special events for prospective students.
• Promoted relationships with other schools, libraries, and association.
• Advisor, Academic Affairs and complied with Higher Educational PA State policy and procedures.
• Created comprehensive instruction and trainings for student affairs division.
• Developed assessment strategy and evaluation instruments for student development.

Confidential,PA 11/2000 – 01/2001
Human Resource Employee Communications Specialist

• Assisted in the determination for products and services
• Performed support materials and visual systems and tutorial modules and web portals for employee’s access.
• Recruiter, Human Resource Staffing and Development.
• Created and maintained database for human resource new employees.
• Assisted and trained SAP with computer-based trainings.
• Created and maintained employee newsletter and incentive programs.

CERTIFICATIONS/HONORS:

• Certification, Technology Educators New Jersey Association
• Certification, State of Pennsylvania Private School Secondary Education
• Certification and Training, Train the Trainee Trainer
• Certification OSHA Trainer - CPR and First Aid
• Clearance and Bonding, FBI and Fingerprint
• Certification, Safety Training, Corporate Ethics-Certification, Infection Control
• Advisor, Academic Success Center, East Stroudsburg University
• Advisor, Mentor Leadership, Montclair State University
• Member, International Society for Technology in Education
• Graduate Student Recipient, Shirley Chisholm 2005 Award, East Stroudsburg University

SKILLS:
Professional Computer Skills - Microsoft Word, Excel, Outlook, Access, PowerPoint and Visio, SharePoint, Compliance Wire, Novell, e-Doc Documentum, Compliance Wire, Proficient-Infinity QS, QAD, Milestone, Dashboard Management, e-Room, Track-wise, Database Management; Web-SS, Change Control Deployment process knowledge, (SDLC)-Software Document Development Lifecycle Testing knowledge, Drafting and Manual Revision and Development, Research and Development Process knowledge, e-Learning development and training methodology, Global Regulatory Strategy (GRS), Learn/Confirm Grid, PDM–Product Dossier Management, Meta-Storm CC Systems, Financial Banking Systems, Prophet, CRM Software CICS, Emerald Systems.