Tech Writer/Editor with QA experience & training/Adult Learning expert

Allison Price Stafford

Cary, North Carolina *****

919-***-**** ***********@*******.***

SUMMARY OF QUALIFICATIONS

Technical Writer, certified Trainer and Lean Six Sigma Quality professional providing regulated industry expertise, SOPs, policies & procedures, process analysis, content development, software rollout/ documentation, and customer support, ready to unravel problems and achieve your desired results. Excellent IT, analysis, editing, training, graphics and communications skills as evidenced by successful projects and well-managed customer relationships. Resourceful, creative and flexible; a strong collaborator & team player. Healthcare, QA/ Compliance & IT background provide a strong foundation for contributing effectively to a wide scope of projects.

SKILLS & EXPERIENCE IN

●Technical Writing/Editing

●Process Improvement

●Change Management / Product/Program Launches

●ITIL/SDLC Expertise

●Effective Presentations

●Business/Gap Analysis

●Marketing & Copywriting

●QA /Compliance, FDA/EPA regs

●Lean Six Sigma (Black Belt)

●Small Project/Program Mgmt

●Problem Solving, Deviations, CAPA

TECHNICAL EXPERTISE

MS Office Suite Expert

Databases (Access, SQL)

MS Project, Teams, Agile PLM

Captivate, Articulate Storyline

SnagIt, Google Docs, SAS

Adobe Acrobat, WebEx, Photoshop

Dreamweaver, FrontPage, HTML

Go-To-Training, JIRA, Confluent

SharePoint, Illustrator, Visio

ERPs, CRMs, SAP, Master Control

FrameMaker, Publisher

LMS: Documentum, GSMU, ComplianceWire, SumTotal webTraining, many others

EDMS: Atlas, Open Text

PROFESSIONAL EXPERIENCE

Medicago USA LLC (Contractor, Amris Consulting) RTP, NC Oct ‘21 – Jan ‘22

●Senior Tech Writer, Updating/creating regulatory policies and procedures, SOPs, training, Batch Records, forms for small pharma, using Master Control, SharePoint, MS Office Suite, Adobe apps.

Teleflex Medical (Contractor, ) Morrisville, NC Mar ‘21 –Aug ‘21

●Tech Writer, Product Labeling, Quality Control, proofreading, SOP and Work Instruction review, updates.

Freelance Writer/Editor Apr ‘20 –Feb‘21

●Tech Writer, Online Content Developer, Instructional Design, &Application Testing for multiple clients.

C3HealthcareRx, Morrisville, NC Sep ‘19 –Mar ‘20

●Quality Spec./Tech Writer – Project lead pursuing HITRUST Cybersecurity Certification. Wrote policy, procedures, and checklists to align company with HIPAA security requirements. Successfully submitted compliant self-assessment, remediating gaps. Designed Implementation program and employee training.

Transcore, LP, (Contractor) Morrisville, NC May ‘19 –Aug ‘19

●Tech Writer– NCTA project, Agile –With SMEs & team created/edited documentation, user guides, charts /diagrams and refined templates. Mapped processes, analyzed data, JIRA, ID’d gaps and tested software.

NC Dept of Information Technology (Contractor, Infojini) Raleigh, NC Feb ‘19 – Apr ‘19

●Tech Writer/Change Agent– Launched (SAAS) ServiceNow application to State Government agencies. Project rollout of ITIL app, performed needs analysis, process documenting and application training.

McKesson Biologics (Contractor, Primus Software corp, GA) Cary, NC Sep ‘18 – Feb ‘19

●Tech Writer/Process Analyst–Analyzed, captured Pharmacy Inventory/Fulfillment processes, assessing risk, recommending changes to improve communication, proceduresand training, driving better metrics.

Micell Technologies (Contractor, People2.0) Cary, NC Mar ‘18 – May ‘18

●QA Tech Writer/GxP Trainer– Provided training, edited/ updated SOPs, Work Instructions, Test Methods. Used InDesign, PowerPoint and Visio to produce or update illustrations, charts, process flow diagrams and other supporting materials for user guides and documents. Supported R&D and Regulatory.

SunTech Medical Inc (Contractor, Aerotek) Cary, NC Aug ‘17 – Dec ‘17

●Tech Writer/ Doc Specialist– Integrated new product line into regulated production systems by translating complex engineering directions into readable, concise instructions including flowcharts, graphs & diagrams.

Cotton Incorporated (Contractor, CDS) Cary, NC Nov ‘15 – Feb ’17

●Technical Writer/Marketer – Using MS Office tools, Adobe CS6 suite, supported major software rollout. Performed software testing, created user guides, job aids, and marketing /training materials. Applied new branding, analyzed and published two ROI studies, demonstrating $ savings, attracting new customers.

Technical Consultant (self-employed) Apr ‘09 – Freelancing to present

-Pharma Specialist - providing regulatory documentation support, FIFRA labeling updates, technical publications and brochures, SOP writing/editing, marketing copy and Training /Event coordination for clients.

-HealthCare Trainer - providing HIPAA and medical records (EMR-EPIC) training using vendor-developed materials for client healthcare providers, insurance companies and medical offices across NC.

-Editor/Reviewer -E-Learning audits, templates, document restructuring, marketing, reviews & proofreading.

-Online Program creation/design –webinar consulting; helped produce web training sessions.

Novartis V&D (Contractor, Artech, Inc) Holly Springs, NC July ‘14 – Sept ‘14

●Training Coordinator–Supported QA in cGMP training & compliance for FDA vaccine bio-manufacturer.

Duke Energy Progress (Contractor, IST, LLC) Raleigh, NC Nov ‘13 – Feb ‘14

●Training & Communications Specialist–Instructional Design, analysis and classes for Smart Grid project targeting diverse internal utility audiences. Supported communications and change management activities.

NC DOT /DMV (Contractor, Randstad Technologies) Raleigh, NC Aug ‘12 – Sep ‘13

●ISD/Trainer/Technical Writer/ QA Software Tester –(OPUS) Developed Officer training program and job aids based on customer requirements. Delivered District ILT classes using Office10, Visio & PowerPoint.

●Wrote/ edited program specifications, Performed complex manual functional & regression software testing, trouble-shooting and analysis. Excelled at finding defects, identifying issues, & influencing for change.

Accenture LLC, Raleigh, NC Sep ‘11 – Jun ‘12

●Content Developer/Trainer– Using SharePoint, PowerPoint, FrameMaker, Connect Pro, and Captivate, developed training content for pilot rollout. Supported PM in scheduling, organizing, & documentation.

●Delivered instructor-led classes for state-wide DHHS project and administered SharePoint site.

Talecris Plasma Resources, (now Grifols), Raleigh, NC April ‘11 – Jun ‘11

●Training Supervisor– In regulated lab environment, provided New Hire orientation, SOP training on regulations and best practice updates. LMS ComplianceWire used to manage staff online training.

City of Raleigh, Raleigh, NC Part-time Aug ‘09 – Oct ‘10

●Training Coordinator (HR) – Student enrollment, tracking, metrics, workflow and SAP-LMS systems.

●Custom course development in PowerPoint, Captivate. Compliance & Ethics delivery, IL & CBT.

●Needs analysis and design for manuals, job-aids, train-the-trainer sessions and employee training.

RTI International, Research Triangle Park, NC 2003 – 2009

Regulatory Affairs Specialist/Corporate Records Manager, Feb 2007 –Jan 2009

●Launched, managed Corporate Records program involving Warehouse disposition, dept. training, SOPs.

●Designed and delivered regulatory training, (e-learning & ILT) using Captivate / PowerPoint.

●Applied adult learning principles using an iterative design methodology to satisfy customer needs. Followed up with application coaching, demonstrations, assessments, job-aids, refreshers and metrics collection.

●Delivered Company-wide Compliance & Ethics training meeting all legal requirements.

Training Specialist II, (Digital Solutions) Oct 2005 - Feb 2007

●Provided instructional design, software testing, scripting, needs analysis, content development, & proposal coordination for multi-year projects delivering Military (Tanks) and Healthcare (Triage) simulations.

●Managed RTI’s ITSEC presence for large International Military conference. All prep & marketing efforts including logistics, customer contacts, demonstrations, training, transportation, hardware & staff schedules.

Training Coordinator, GLP Archivist, (Quality Assurance Unit) Jul 2003 - Oct 2005

●Records and GLP Archive inventory management, quality process improvement, database consolidation, and computer validation support for Auditing and Toxicology staff of 70.

●Regulatory GxP and records training involving development, delivery, progress tracking and evaluation.

●Organized and administered regulated R&D SOP system; designed author training for new SOP writers.

GlaxoSmithKline, Research Triangle Park, NC 1990 - 2002

Project Manager, Learning and Organizational Development 2001 - 2002

●Instructional designer, coordinator and trainer for international corporate group.

Regulatory Specialist, Worldwide QA & Compliance, Glaxo Wellcome 1995 - 2000

●Managed SOP Systems group, trained as auditor in GLP, cGCP, GMP and Computer Validation.

●Demonstrated strong skills in Project Mgmt, New Hire Orientation, IT liaison and trainer, SOP Administration, Records/Document Management. Instructor for Compliance & Ethics and KT Problem Solving.

Technical Analyst/Programmer, Lab Automation Systems Support, Burroughs Wellcome 1990 – 1995

EDUCATION

- BA, UNC-Chapel Hill - Post Grad Computer Science Certificate, NCSU, Raleigh, NC

CONTINUING EDUCATION

-Articulate Storyline – Adobe, Mar 2016 ● Instructional Design (Agile Environment)- ProEdit, Oct 2014

- GMP Refresher and Advanced GMP Practice, NC Biotech Center, Apr 2012.

- Webmaster Certificate Program – coursework complete – NCSU CTU ● SharePoint Classes 2015

- Certified Instructor, Kepner-Tregoe: Problem Solving & Decision Making, Project Management.

Franklin-Covey: Scientific Writing. DDI: Principles of Supervision, Leadership Excellence, Developing People

- Certified Instructional Designer, Training Manager: Langevin Training Services, Ontario, Canada

- Certified Black Belt,Lean Six Sigma, Certification Professionals, January 2020.

PROFESSIONAL SOCIETIES

Association of Talent Development (ATD-RTA) Society of Technical Communicators (STC) Raleigh Chapter

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