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
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
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