Quality Assurance Specialist

3 days ago


Bothell, Washington, United States Futran Tech Solutions Pvt. Ltd. Full time

Futran Tech Solutions Pvt. Ltd. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for maintaining shop floor quality presence, dispositioning in-process materials and finished product, and investigating and resolving GDP errors. You will also perform batch record reviews to ensure the quality of manufactured products complies with all applicable regulations and guidelines.

The ideal candidate will have a strong understanding of biotech product manufacturing and US and EU cGMP regulations and guidance. You will also have experience with Oracle, BMRAM, MES, and Veeva Infinity. Additionally, you will be able to draft and review specifications and SOPs, monitor and trend batch record errors, and provide guidance to less experienced staff.

Key Responsibilities:

  • Perform general and/or complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
  • Inspect and release intermediates or packaged drug product per specifications.
  • Monitor various stages of processing along with the appropriate paperwork in compliance with specifications.
  • Draft and review specifications and SOPs.
  • Monitor and trend batch record errors and provide Quality Assurance management with quality indicator data.
  • May provide guidance to less experienced staff.

Requirements:

  • B.S. in Biology, Chemistry, or related discipline, or its equivalent is preferred.
  • 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
  • Knowledge of biotech product manufacturing.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of Oracle, BMRAM, MES, and Veeva Infinity are a plus.


  • Bothell, Washington, United States AtWork Group Full time

    Job Title: Quality Assurance SpecialistAt AtWork Group, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest standards of quality.Key Responsibilities:Inspect and audit materials, processes, and products to ensure conformance with quality...


  • Bothell, Washington, United States Terex Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a Quality Assurance Specialist to join our team at Terex. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Compile and analyze quality data related to purchased component non-conformancesUpdate supplier...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: Quality Assurance SpecialistOmni Inclusive is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality operations department, you will play a critical role in ensuring the highest standards of quality in our manufacturing processes.Key Responsibilities:Lead and facilitate deviation triage, initiation,...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Summary: Omni Inclusive is seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for maintaining shop floor quality presence, dispositioning in-process materials and finished product, investigating and resolving GDP errors, and performing batch record reviews. Key Responsibilities: ...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: Quality Assurance SpecialistLocation: Bothell, WA*100% onsiteWork Schedule: Sunday-Wednesday, 9PM - 7:30AM PST*Top Skills Documentation Review experience Scientific Degree Experience working in a GMP environment*Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.Maintains a high level of...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: QA Associate Specialist Document ControlAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to support our document control operations at our Bothell site. As a key member of our team, you will be responsible for managing our electronic document system, reviewing and approving document change requests, and troubleshooting...


  • Bothell, Washington, United States Insight Global Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Insight Global. As a key member of our quality assurance team, you will be responsible for ensuring the quality and compliance of our products and services.Key ResponsibilitiesAuthor, review, and approve SOPs and other controlled documentsManage change controls...


  • Bothell, Washington, United States Insight Global Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Insight Global. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key ResponsibilitiesAuthor, review, and approve SOPs and other controlled documentsManage...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title:Senior Specialist, Quality AssuranceJob Summary:The Senior Specialist, Quality Assurance position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant. This individual contributor role is responsible for leading/facilitating triages, deviation approvals, and CAPA records through the electronic quality...


  • Bothell, Washington, United States Romac Industries Full time

    Quality Assurance InspectorRomac Industries is seeking a Quality Assurance Inspector to join our team. As a Quality Assurance Inspector, you will play a crucial role in ensuring our products meet the highest standards.Responsibilities:Inspect and verify parts using precision tools and ensure they match blueprints and work orders.Review material test reports...


  • Bothell, Washington, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job DescriptionFutran Tech Solutions Pvt. Ltd. is seeking a highly skilled Quality Assurance Associate to join our team. The successful candidate will be responsible for maintaining shop floor quality presence, investigating and resolving GDP errors, and performing batch record reviews.Key Responsibilities:Perform general and/or complex manufacturing...


  • Bothell, Washington, United States Randstad Full time

    Quality Assurance InspectorWe are seeking a detail-oriented Quality Assurance Inspector to join our team at Randstad. The ideal candidate will be responsible for conducting thorough quality inspections of medical devices, utilizing various measuring tools and vision inspection systems to identify defects or deviations from specifications.Key...


  • Bothell, Washington, United States Terex Full time

    Job Title: Supplier Quality EngineerJob Summary:We are seeking a highly skilled Supplier Quality Engineer to join our team at Terex. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our purchased components and materials.Main Responsibilities:Compile and analyze quality data related to purchased component...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Title: Quality Assurance Document Control SpecialistLocation: RemoteAbout the Role:The Quality Assurance Document Control Specialist supports the cGMP Document Control operations for the Client site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Document Control Specialist to join our team at Omni Inclusive. The successful candidate will be responsible for supporting the cGMP Document Control operations for Client Jump site records management.Key ResponsibilitiesReceiving and reconciliation of GMP recordsManagement of scanning, archival,...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Document Control Specialist to support our cGMP Document Control operations for the Client Jump site. The successful candidate will be responsible for managing the document change control process, issuing and reconciling batch records, and managing archival and retention of GMP records.Key...


  • 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 crossfunctionally and to develop and maintain strong business partner relationships....


  • Bothell, Washington, United States Year Up United Careers Full time

    Launch Your Career with Year Up United CareersAre you ready to take the first step towards a successful career in Quality Assurance? Year Up United Careers offers a one-year intensive job training program that provides young adults with in-classroom skill development, access to internships, and personalized coaching and mentorship.What You'll...


  • Bothell, Washington, United States Omni Inclusive Full time

    Job Summary:Omni Inclusive is seeking a highly skilled Quality Assurance Document Control Specialist to support the cGMP Document Control operations for Client Jump site records management. The successful candidate will be responsible for receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.Key...


  • Bothell, Washington, United States Terex Corporation Full time

    Job SummaryWe are seeking a highly skilled Transportation Quality Manager to join our team at Terex Corporation. As a key member of our quality assurance team, you will be responsible for ensuring that all goods and services transported meet the highest quality standards.This role is crucial for ensuring that the transportation industry functions at the...