SUMMARY:

• Accomplished senior - level technical analyst with extensive experience providing analysis of requirements and writing for end users and system integrators in the computer and pharmaceutical industries.
• Extensive experience consulting with SMEs, business managers and other technical experts to determine requirements for proposed and existing (improvement of productivity) hardware and software systems.
• Extensive analysis experience for a wide range of projects and scopes of work including LabWatch design and installation.
• Extensive experience writing a wide variety of technical and regulatory documents, including hardware and software manuals, product specifications, white papers, and maintenance and testing procedures (FAT, UAT, etc.)
• Extensive experience using industry-standard authoring and publishing tools, including Microsoft Windows Publisher, Microsoft Word, and Adobe Acrobat.
• Extensive experience developing and implementing templates and processes for a wide variety of industrial processes using Visio Technical, Publisher, and Word.
• Extensive experience creating and modifying illustrations as necessary using a variety of popular graphics programs, including Microsoft Visio 2019 and SmartDraw.
• Highly skilled in successfully managing simultaneous writing projects and coordinating simultaneous deliverables.

PROFESSIONAL EXPERIENCE:

Confidential (Cary, NC)

Senior Technical Writer

Responsibilities:

• Updated and verified sops, work instructions (WI), Information for Safety Sheets (IFSS) as required for all program areas across the campus.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis between existing system and proposed new system.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.

Confidential (Dudley, NC)

Senior Technical Writer

Responsibilities:

• Updated and verified sops, work instructions (WI), Information for Safety Sheets (IFSS) as required for all program areas across the campus.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis between existing system and proposed new system.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.

Confidential (Atlanta, GA)

Senior Technical Writer

Responsibilities:

• Assisted in documenting User Requirements, Functional Design, System Design and any other documents required to install, commission, test, and go live for Confidential Software at USPS IT Technology.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.
• Documented hardware design for Confidential Software

Confidential (Raleigh, NC)

Senior Technical Writer

Responsibilities:

• Updated and verified sops, work instructions (WI), Information for Safety Sheets (IFSS) as required for all program areas across the campus.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis between existing system and proposed new system.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.

Confidential (Durham, NC)

Senior Technical Writer

Responsibilities:

• Updated and verified sops, work instructions (WI), Information for Safety Sheets (IFSS) as required for all program areas across the organization.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis between existing system and proposed new system.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.
• Conducted one-on-one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis for various projects including CTMS and e.
• Provided detailed analysis of Quintiles Requirements as compared to Eagle Creek Requirements.
• Updated and verified sops, work instructions (WI) as required for ELVIS Content project based on gap-analysis and consulation with SMEs.
• Designed and prepared complex process flow diagrams for various projects
• Updated and maintained CTMS process diagrams for Release 1, 2 and 3
• Updated and restructured business requirements for CTMS - Release 1, 2, and 3
• Provide a written analysis for differences between CTMS R1-2 flow diagrams and CTMS R3 flow diagrams.
• Prepared SDS for outsourcing development of programming code for CV project and EEL Content.

Confidential (Durham, NC)

Senior Technical Writer

Responsibilities:

• Updated and verified sops, work instructions (WI), Information for Safety Sheets (IFSS) as required for all program areas across the campus.
• Conducted one on one meetings with SME’s and other staff for new documents as required.
• Provided gap-analysis between existing system and proposed new system.
• Designed and prepared complex process flow diagrams and electronic forms for SOPs and WIs.

Confidential

Senior Technical Analyst

Responsibilities:

• Reviewed network drawings and updated drawings to reflect current configuration. This included walking the equipment down to verify that the equipment was installed in the current racks. Verified the UPS power sources for each chassis and equipment rack.
• Prepared new complex drawings and a detail drawing of the data center. Drawing was done to scale and verified for accuracy.

Confidential (Durham, NC)

Senior Technical Writer/Validation

Responsibilities:

• Updated and validated user documentation for a go-live installation of SAP against a very aggressive schedule.
• Wrote, reviewed (analysed), and standardized SOPs, Forms, and Data standards required for the go-live date.
• Designed and prepared complex process flow diagrams and electronic forms for SAP Data Custodians.

Confidential (Northridge, CA)

Senior Technical Writer/Validation

Responsibilities:

• Prepared and reviewed USR for an upgrade of the ProCal V5 Calibration and Maintenance System against a very aggressive schedule.
• Wrote and reviewed Installation Qualifications (IQ), Operational Qualifications (OQ), and Standard Operating Procedures (SOP) for an upgrade of the ProCal V5 Calibration and Maintenance System.

Confidential (Clayton, NC)

Senior Technical Writer/Validation

Responsibilities:

• Prepared and reviewed reports for FDA submission against a very aggressive schedule.
• Wrote and reviewed reports for Engineering Test Plans for various departments and equipment to help close incidents and deviations.
• Designed and prepared complex chart graphs for data presentations.

Confidential (Morrisville, NC)

Senior Technical Writer/Validation

Responsibilities:

• Updated and validated user documentation for a new product (Dosimeter Verification System) against a very aggressive schedule.
• Wrote, reviewed, and executed Installation Qualifications (IQ), Operational Qualifications (OQ), and Standard Operating Procedures (SOP) for Dosing Station.
• Designed and prepared complex process flow diagrams for DVS Dosing Station using Visio Technical 2003.
• Developed and documented templates, processes, and procedures for installation of a new PenFill line (Insulin) using Word and Visio Technical 2003.
• Developed and documented Validated System Change Request (VSCR) for PenFill Line 3 using Word.

Confidential (Wilson, NC)

Senior Technical Writer

Responsibilities:

• Analysed business requirements for implementation of new Calibration and Maintenance tracking system.
• Wrote and created technical documents necessary to install and validate a new Calibration and Maintenance tracking system against a very aggressive schedule.
• Wrote and updated engineering product specifications.
• Modified and updated as necessary reports for ProCal V5 using Crystal Reports.
• Analysed needs and developed a new curriculum to merge the existing Industrial Technology program with the Bioprocess Technology program. The intention was to educate a new type of biotechnology technician that would understand the importance of the work they do in the pharmaceutical/biotechnology sector of industry.
• Prepared documentation necessary to add program to curriculum including curriculum, letters of introduction, course requirements, equipment list, etc.
• Created brochures and flyers to advertise and promote the new curriculum.

Confidential (Clayton, NC)

Senior Technical Engineer

Responsibilities:

• Analysed requirements for a wide variety of projects and determined hardware and software suitable for each project based on final requirements determination.
• Provided technical support for a wide variety of projects including a major upgrade of process equipment used in the Clinical Manufacturing Facility (CMF).
• Wrote, created illustrations for, and released a complete documentation set for a new drive control system in the “old” section of CMF.
• Automated tank agitator control system against a very aggressive schedule to allow client to close a potentially lucrative new pharmaceutical drug agreement.
• Provided validation support for a wide variety of projects including laboratory equipment monitoring upgrade, temperature control project, freeze dryer “E” project and double dipper modifications required for safety.
• Created and modified complex process control diagrams and process instrumentation diagrams (PID) using Visio Technical and other graphic packages including MicroStation.
• Provided leadership on complex documentation projects and coordinated the production of multiple simultaneous deliverables.
• Validated and tested LabWatch monitoring system ensuring that all CFR 21 Part 11 requirements were meet and tested.
• Worked with upper engineering to develop a system to ensure that CFR 21 Part 11 requirements were built into all new systems and retrofitted on old system.