Natesa Richardson
Project Manager And Technical Writer
Sacramento,CA
Overview
10
10
years of professional experience
6
6
Certifications
Work History
Quality Assurance Specialist/Technical Writer
MILIPORE SIGMA
03.2024 - Current
- Verify label documentation that includes product label forms, photos, photo forms, IFUs, and validations for IVDR certification in Europe and ongoing IVD certification in multiple countries
- Create and Edit IFUs in Adobe InDesign and Lytho
- Document IVDR and IVD updates, audits, and CAPA in Track-Wise task management
- Coordinate tasks and manage timelines of new and existing projects within R&D, Marketing, Regulatory Quality, and Manufacturing to ensure successful & sustainable project development
- Lead and write software validation risk assessments
- Perform Internal ISO 13485 Audits
- Technical Writer/Validation Document Engineer of Software Modifications – Crafted and Approved VP, URS, FS/DS, TM, IQ, OQ, PQ templates in MS Word and MS Excel
- Validation Document Engineer of Software Modifications – Managed Computer System Risk Assessments Meetings and Created Assessments for each Software Modification
- Software Validation Engineer– Performed IQ, OQ, PQ operations within desktop and web platforms in a GxP environment
Project Manager/Technical Writer
MILIPORE SIGMA
03.2023 - 03.2024
- Managed, communicated, developed, and edited labeling documentation that includes product label forms, photos, photo forms, IFUs, and validations for IVDR certification in Europe and ongoing IVD certification in multiple countries
- Documented IVDR and IVD updates, audits, deviations, and CAPA in Track-Wise task management
- Coordinated tasks and managed timelines of new and existing projects within R&D, Marketing, Regulatory Quality, and Manufacturing to ensure successful & sustainable project development
- Technical Writer/Validation Document Engineer of Software Modifications – Crafted VP, URS, FS/DS, TM, IQ, OQ, PQ templates in MS Word and MS Excel
- Validation Document Engineer of Software Modifications – Managed Computer system Risk Assessment Meetings for each Software Modification
- Validation Documentation Engineer– Performed IQ, OQ, PQ operations in descriptive and web platforms
Technical Writer/Project Manager
SEQUOIA BIOTECH CONSULTING
09.2021 - 11.2022
- Revised, generated, converted, and translated complex technical documents required for various functions (i.e
- Quality, Facilities, Manufacturing, Computer System Validation) with clinical and ISO 13485 auditing expertise
- Edited Computer System Validation Documents with Lithuanian Team Members
- Led, taught, and organized a technical writing team in reviewing equipment records, editing, and delivering operating procedural and work instructions documents for the manufacturing team
- Coordinated, managed, and approved documents in a data management system for an International Private Biotech Company as a document control analyst
- Edited and constructed procedural documents for software validations in manufacturing and quality
- Organized and posted regular informative cultural topics as one of the Diversity ambassadors
Research Associate, Product Development & Quality/Technical Writer
EVOLVE BIOSYSTEMS (RENAMED IN 2022: INFINANT HEALTH)
09.2020 - 09.2021
- Organized and led meetings to discuss improvements in product quality tests and development
- Created and revised procedural documents for the quality department
- Scheduled and tracked probiotic powder product quality testing and shipments via ASANA
- Performed quality checks and reported data analysis through Excel and Sharepoint for operation
- Collaborated with the Supply Chain Manager and Perform stability testing on probiotic products to determine shelf half-life in various climates and conditions
- Sent products for additional diagnostic testing and recorded results for commercial use
- Investigated, planned, performed, wrote, and reviewed supplier audits and CAPA with the Quality team
- Managed laboratory supplies orders and delegated lab management tasks
Technical Writer
HB STAFFING (CLIENT: U.S. FISH & WILDLIFE SERVICE, VIRGINIA DEPT. OF THE INTERIOR)
07.2020 - 09.2020
- Organized periodic meetings, communicated, and collaborated with scientists and others on revisions of scientific details in 400+ page biological opinion document
- Edited grammar, applied active voice, formatted text & tables, and wrote additional scientific information within the biological opinion
- Created how-to instructions on Excel features relevant to research needs
Technical Writer/Research Technician
BASF CORPORATION, NUNHEMS
12.2014 - 12.2019
- Communicated, wrote, and edited technical documents like operational procedures, quick guides, and templates for the plant pathology department
- Managed, received, and compiled revisions to tables, appendices, and content within technical documents through Word, Excel, PowerPoint, and Adobe Acrobat on time
- Strategized on new pathology techniques, experimented, and implemented new methods for seed and crop effectiveness against viruses, fungi, and bacteria pathogens
- Led safety meetings, strategized ergonomic lab improvements, and implemented safety regulations as a Safety Committee Member
- Presented and posted regular leadership information as a Women Leadership Member
Education
Bachelor of Science - Environmental Systems
University of California- San Diego
Project Management Course and Certification - undefined
Pryor Learning
36 Hour QMS Lead Auditor Course - ISO 9001:2015, ISO 13485: 2016
Oriel Stat A Matrix
Skills
Technical Writing
Document Management
MadCap Flair
Data Analysis
Partner Strategy
Communication
Trackwise Change Control
People Management
ISO 13485: 2016
Auditing
GMP
Project Management
Software Validations
SAP
Data Integrity
GLP
Research
Marketing
Graphic Design
Content Management
Adobe
Microsoft
European Union Medical Device Regulation
US FDA of EMED products
Certification
Pryor Learning, Project Management Course and Certification, 02/01/23
Personal Information
Relocation: Open to Relocation and Telework
Timeline
Quality Assurance Specialist/Technical Writer
MILIPORE SIGMA
03.2024 - Current
Project Manager/Technical Writer
MILIPORE SIGMA
03.2023 - 03.2024
Technical Writer/Project Manager
SEQUOIA BIOTECH CONSULTING
09.2021 - 11.2022
Research Associate, Product Development & Quality/Technical Writer
EVOLVE BIOSYSTEMS (RENAMED IN 2022: INFINANT HEALTH)
09.2020 - 09.2021
Technical Writer
HB STAFFING (CLIENT: U.S. FISH & WILDLIFE SERVICE, VIRGINIA DEPT. OF THE INTERIOR)
07.2020 - 09.2020
Technical Writer/Research Technician
BASF CORPORATION, NUNHEMS
12.2014 - 12.2019
Bachelor of Science - Environmental Systems
University of California- San Diego
Project Management Course and Certification - undefined
Pryor Learning
36 Hour QMS Lead Auditor Course - ISO 9001:2015, ISO 13485: 2016
Oriel Stat A Matrix