TotalMed Case Management StaffingEverett
TotalMed Case Management Staffing is seeking a travel nurse RN Home Health for a travel nursing job in Everett, Washington. TotalMed Case Management Staffing Job ID #1498395. About TotalMed Case Management Staffing. ...
Core Medical GroupMill Creek
EMR - Clinicient CoreMedical Group has hundreds of exciting and rewarding travel assignments throughout the country for Travel Allied Professionals and Travel Nurses.Plus, we're the only healthcare staffing company to offer our travelers a free, all-inclusive tropical vacation.You can earn our Club ...
Everguard MaterialsTukwila
Job Overview:** We are seeking a energized team player to join our growing team to delivery materials to our local customers.The ideal candidate will be responsible for transporting goods and materials over short or long distances while operating a variety of trucks • *Responsibilities:** - Safely o...
Disney ExperiencesSeattle
We are responsible for the end-to-end digital and physical Guest experience for all technology & digital-led initiatives across the Attractions & Entertainment, Food & Beverage, Resorts & Transportation and Merchandise lines of business as well as other initiatives including MyDisneyExperience and H...
FFSS- FUJIFILM SonositeBothell
Overview
Senior Data Management Specialist - Bothell, WA
FUJIFILM Sonosite, Inc. -- If you are looking for work that matters, you’ll find it at FUJIFILM Sonosite. As the creator of point of care ultrasound, we dedicate every day to the innovation...
Fidelity TalentSource LLCBellevue, 9 mi from Bothell
Job Description:
Wealth Management Planning Consultant
For you, client interactions aren t just transactions. They re relationships that need to be nurtured. Our mission is to build strong, personal relationships with our clients and thats a key...
CGS Business Solutions | INC 5000 CompanySeattle, 12 mi from Bothell
are currently seeking Technical Professionals who are searching for challenging and rewarding jobs for the following opportunity:
CGS has a BRAND NEW opportunity for a Telecommunications Manager (IT/MDM/EMM/Expense Management) to work on a contract to hire...
Valet LivingBothell
Join our team as an Apartment Trash Collector (Service Valet) and enjoy the convenience of flexible evening hours in your local area. Whether you're looking to supplement your income or earn extra money alongside another job, this position offers the...
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Technical Writer
Bothell | www.resume-library.com |
TOP SKILLS:
" 1-2+ years managing GMP Documents
" 1-2+ years of MS Office 365
" 1+ years working in quality systems or project work
Position Summary
The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.
Duties/Responsibilities
Primary responsibilities include:
" Managing document revision workflows in an electronic document management system for Manufacturing, which includes reviewing and approving document change requests, editing documents and incorporating SME input.
" May own and revise Manufacturing procedures including participating on project teams as a key stakeholder.
" Collaborate with Quality Systems record owners to complete change and CAPA action deliverables.
" Follow Policies, SOPs, and work instructions to support the document revision process.
" Track in flight document workflows and provide status updates as required.
" Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
" Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
Qualifications
Education: Bachelor's degree or equivalent combination of education and experience
Experience Basic Qualifications:
" Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.
" Strong communication and customer service skills.
" Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
" Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
" Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
" Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
" Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
" Possess project management skills.
" Experience interacting with FDA or other regulatory agencies preferred.
" Knowledge of cGMPs and regulatory requirements.
" Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
" Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
" 1-2+ years managing GMP Documents
" 1-2+ years of MS Office 365
" 1+ years working in quality systems or project work
Position Summary
The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.
Duties/Responsibilities
Primary responsibilities include:
" Managing document revision workflows in an electronic document management system for Manufacturing, which includes reviewing and approving document change requests, editing documents and incorporating SME input.
" May own and revise Manufacturing procedures including participating on project teams as a key stakeholder.
" Collaborate with Quality Systems record owners to complete change and CAPA action deliverables.
" Follow Policies, SOPs, and work instructions to support the document revision process.
" Track in flight document workflows and provide status updates as required.
" Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
" Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
Qualifications
Education: Bachelor's degree or equivalent combination of education and experience
Experience Basic Qualifications:
" Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.
" Strong communication and customer service skills.
" Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
" Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
" Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
" Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
" Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
" Possess project management skills.
" Experience interacting with FDA or other regulatory agencies preferred.
" Knowledge of cGMPs and regulatory requirements.
" Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
" Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
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