Quality Assurance Document Manager

7 days ago


Bothell, Washington, United States Omni Inclusive Full time

We are looking for a motivated and proactive Quality Assurance Document Manager to support our cGMP document control operations. The successful candidate will be responsible for managing controlled documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional departments.

The key responsibilities of this role include:

  • Managing an electronic document system, including reviewing and approving document change requests and troubleshooting issues.
  • Collaborating with cross-functional departments to finalize time-sensitive deliverables.
  • Ensuring compliance with regulatory requirements, including cGMPs and domestic regulatory requirements.
  • Providing communication on the status of Quality Systems deliverables to customers, management, and stakeholders.

This position requires strong organizational and analytical skills, as well as experience with MS Office and quality systems. A bachelor's degree or equivalent in a relevant field is also required.



  • Bothell, Washington, United States Omni Inclusive Full time

    Omni Inclusive is a dynamic company that requires a skilled and organized Quality Assurance Document Coordinator. This individual will support the cGMP Document Control operations for our Client Jump site by managing controlled documents, conducting audits, and communicating with stakeholders.Key Responsibilities:Schedule Production Support: Issuing...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    Job OverviewImmunome, a clinical-stage targeted oncology company, is seeking an experienced Senior Manager/Associate Director, Quality Assurance. This role will be responsible for overseeing batch record review, change controls, deviations, and CAPAs. The successful candidate will work closely with Contract Manufacturing Organizations (CMOs) to release...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    About the RoleWe are looking for a highly skilled Senior Manager/Associate Director, Quality Assurance to join our team. In this role, you will be responsible for ensuring the quality and regulatory compliance of our Small Molecule and Antibody Drug Conjugate (ADC) portfolio.You will work closely with the Contract Manufacturing Organization (CMO) to release...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    Senior Manager/Associate Director, Quality AssuranceBothell, Washington, United StatesCompany OverviewImmunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that...


  • Bothell, Washington, United States Romac Industries Full time

    Company OverviewAbout Romac IndustriesRomac is committed to 'connecting people to water,' manufacturing innovative and high-quality American waterworks products, and exceeding our customers' expectations. Salary RangeCompensation Package$72,900-$109,400 per year, depending on experience. A competitive compensation package that rewards your skills and...


  • Bothell, Washington, 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 Bristol-Myers Squibb Full time

    Work with a PurposeAt Bristol-Myers Squibb, we are dedicated to transforming patients' lives through science. Our unique work environment offers opportunities for growth and development in every department. As a Senior Quality Assurance Specialist, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes.Key...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    Job Description:Immunome is a clinical-stage targeted oncology company committed to developing innovative therapies for cancer patients. Our portfolio includes varegacestat, a gamma secretase inhibitor in Phase 3 trials for desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand.We seek an experienced Senior...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    Job SummaryWe are seeking an experienced Senior Manager/Associate Director, Quality Assurance to support our Small Molecule and Antibody Drug Conjugate (ADC) portfolio. This role will be responsible for overseeing the batch record review, change controls, deviations, CAPAs, and other aspects of QA operations associated with batch release.This individual will...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    About the Job:Immunome is a leader in targeted oncology, developing first- and best-in-class therapies for cancer patients. We're seeking a skilled Senior Manager/Associate Director, Quality Assurance to join our team. In this role, you'll oversee QA operations, ensuring the highest quality standards are met.Your responsibilities will include:Collaborating...


  • Bothell, Washington, United States Romac Industries Full time

    About the Role">We are seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will play a crucial part in ensuring the quality of our products.ResponsibilitiesYou will be responsible for conducting inspections and assessments of finished goods, including dimensional, welds, finish, markings, and component...


  • Bothell, Washington, United States Bausch & Lomb Full time

    Job Overview:We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. Our goal is to provide essential care to millions of people globally.We seek dedicated individuals who share our sense of urgency, unity, and excellence. If you embody these values, come join our company and help us...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: Senior Specialist, Quality AssuranceLocation: Bothell, WA** 100% Onsite*TOP SKILLS*- 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.-...


  • Bothell, Washington, United States Omni Inclusive Full time

    We seek a dedicated and detail-oriented Controlled Documents Specialist to join our Quality Assurance team at Omni Inclusive. The selected individual will be responsible for controlling and maintaining accuracy of all controlled documents, ensuring compliance with regulations and industry standards.Responsibilities:Document Review and Approval: Reviewing and...


  • Bothell, Washington, United States Romac Industries Full time

    Job OverviewRomac Industries is seeking a highly skilled Quality Assurance professional to join our team. In this role, you will play a crucial part in ensuring the quality of our products meets the highest standards.


  • Bothell, Washington, United States INTELLECTT INC Full time

    We are looking for a talented Quality Assurance Engineer - Mechanical to join our team at Intellectt Inc. The successful candidate will be responsible for ensuring the quality of our products through verification & validation (V&V) testing.The ideal candidate will have strong knowledge of design controls and experience with medical device V&V. They will also...


  • Bothell, Washington, United States Tbwa ChiatDay Inc Full time

    Senior Manager/Associate Director, Quality AssuranceBothell, Washington, United StatesCompany OverviewImmunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that...


  • Bothell, Washington, United States Kelly Science, Engineering, Technology & Telecom Full time

    PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.Kelly Science & Clinical is seeking a Senior Director/Director of Clinical Quality Assurance (CQA) for a direct hire position at a...


  • Bothell, Washington, United States Kelly Science, Engineering, Technology & Telecom Full time

    PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please (1) apply and (2) email your resume directly to: Regan.Brown@KellyScientific.com.Kelly Science & Clinical is seeking a Senior Director/Director of Clinical Quality Assurance (CQA) for a direct hire position at a...


  • Bothell, Washington, United States Clinovo Full time

    About the jobDescriptionCompany OverviewImmunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and...