Document Management Specialist

5 days ago


Bothell, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: Quality Technical Writter

Duration: 12 Months

Location: Bothell, WA


Position Summary

The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the Client Bothell site by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.

Primary responsibilities include:

• Support the implementation of the eMES Enterprise Resource Program and development and integration of Syncade MES at the Bothell site.

• 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.



  • Bothell, United States Sunrise Systems, Inc. Full time

    Job Title: Document Control SpecialistLocation: Bothell, WashingtonDuration: 12 Months contract on W2TOP SKILLS:• Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.• 1-2+ years of MS Office 365• 1+ years working in quality systems or project workPosition SummaryThe Manufacturing (MFG) Tech Writer supports the...


  • Bothell, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Assurance SpecialistLocation: Bothell, WADuration: 12+ monthsJob Description:In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.Perform procedural administration...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: Quality Assurance Document Control SpecialistAt Omni Inclusive, we are seeking a highly skilled Quality Assurance Document Control Specialist to join our team. This is a full-time contract position that will be working with us for 12 months until December 2024.The estimated salary for this position is $80,000 per year.This role will support the...


  • Bothell, Washington, United States Synectics Inc Full time

    We are seeking a skilled Manufacturing Documentation Specialist to join our team at Synectics Inc. This is a full-time position with competitive compensation and benefits.About the Role:This position supports the implementation of Enterprise Resource Programs for Manufacturing Operations by managing document revision workflows, including the document change...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Summary:The Quality Assurance Document Control Associate Specialist supports the cGMP Document Control operations for Client Jump site records management.Responsibilities:Receiving and reconciliation of GMP recordsManagement of scanning, archival, and retention of GMP recordsAssisting with managing the Document Center Archive roomFollowing policies,...


  • Bothell, United States Omni Inclusive Full time

    Must Have List: 5+ years of experience with the following: -Library Science -MS Office including Word, Adobe, Visio. -Document Scanning experience -FDA Documentation & Compliance like 21 CFR Part 11/CGMP -Ability to manage competing priorities -Accuracy and Attention to Detail Schedule: This person may be required to work weekends. End date for this contract...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job DescriptionOmni Inclusive is looking for an experienced Document Management and Compliance Expert to join our team. This is a full-time contract position that will be working with us for 12 months until December 2024.The estimated salary for this position is $85,000 per year.In this role, you will support the cGMP Document Control operations for Client...


  • Bothell, United States TSR Consulting Services, Inc. Full time

    Job Title: Technical Writer12+ month contract - fully onsite TOP SKILLS:• Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.• 1-2+ years of MS Office 365• 1+ years working in quality systems or project workPosition SummaryThe Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs...


  • bothell, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Assurance SpecialistLocation: Bothell, WADuration: 12+ monthsJob Description:In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.Perform procedural administration...


  • bothell, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Assurance SpecialistLocation: Bothell, WADuration: 12+ monthsJob Description:In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.Perform procedural administration...


  • Bothell, Washington, United States Joulé Full time

    Job OverviewJoulé seeks a skilled Documentation Support Associate to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the accuracy and completeness of our documentation.


  • Bothell, Washington, United States Environmental Quality Management, Inc. Full time

    We are seeking an Environmental Remediation Specialist to join our team at Environmental Quality Management, Inc. in Bothell, WA.As a member of our emergency response and rapid services contractor team, you will work under varied site conditions to contain and remove hazardous materials from the environment. Your activities may include demolition, soil...


  • Bothell, Washington, United States Optum Full time

    Role Overview:Optum is a clinician-led care organization committed to delivering exceptional healthcare. We seek a skilled Clinical Cardiology Specialist to join our team in Seattle, WA.Salary and Benefits:The salary range for this role is $109,513 to $160,000 per year. In addition to your compensation, you'll enjoy a comprehensive benefits package,...


  • Bothell, United States Randstad Full time

    qa documentation, operations, and validation support- first shift. bothell , washington posted november 20, 2024 job details summary $30 - $32.39 per hour contract high school category life, physical, and social science occupations reference49445 job details job summary: Why Patients Need You Everything we do, every day, is in line with an...


  • Bothell, Washington, United States Environmental Quality Management, Inc. Full time

    Job DescriptionWe are seeking an experienced Environmental Remediation Specialist to join our team in Bothell, WA.This role will involve working on emergency response and rapid services projects for the U.S. Environmental Protection Agency, containing and removing hazardous materials from the environment under varied site conditions.Key responsibilities...


  • Bothell, Washington, United States Synectics Full time

    **Job Summary:**We are seeking a highly skilled Inventory Management Specialist to join our team at Synectics. This role will be responsible for ensuring the efficient management of inventory, from receiving and inspection to storage and issuance.**Key Responsibilities:**Inventory Control: Implement and maintain effective inventory control processes,...


  • Bothell, Washington, United States Debris to Green Recycling Full time

    Job DescriptionThe Government Contracts Specialist will have knowledge of government contract processes, understanding of request for proposal (RFP) bidding and procurement process, compliance within the recycling and solid waste industries in WA. This role is responsible for managing and securing government contracts, monitoring and responding to upcoming...


  • Bothell, Washington, United States Optum Full time

    About the RoleWe are seeking a skilled Advanced Care Specialist to join our Senior Community Care team at Optum. As an integral part of our interdisciplinary care team, you will provide comprehensive assessments, manage members with acute medical situations or exacerbations of chronic conditions, and ensure accurate documentation.Key ResponsibilitiesConduct...

  • Contract Specialist

    4 weeks ago


    Bothell, United States Debris to Green Recycling Full time

    Title: Government Contracts SpecialistReports to: Sr. Environmental Compliance DirectorFLSA Status: Exempt SalaryWe are excited to share this opportunity to work with DTG Recycle, where we are as focused on sustainability and the environment as we are on our people. You will be part of a passionate group of people making a real and lasting positive effect on...


  • bothell, United States Axelon Services Corporation Full time

    Pay Rate - $22/hr- $24/hr Job Description: Job Title: Benchtop Support SpecialistLocation: Bothell, WA* 100% OnsiteScheduled: Flexible to work between 6am and 11pm rotating shifts and on weekendsTop Skills:- Cyber Security Knowledge preferred- Understanding and experience with Network, databases, servers, and PCs- 3+ years of Experience Planning and leading...