Quality Risk Management Specialist
4 days ago
We are seeking a highly skilled Quality Risk Management Specialist to join our team at Katalyst Healthcares and Life Sciences. As a key member of our Quality Systems team, you will be responsible for maintaining the Quality risk management program at our manufacturing facility.
The successful candidate will have a minimum of 5 years of relevant Quality experience in a GMP/FDA regulated environment and a strong understanding of Quality Risk Management principles and application within quality systems. You will be responsible for contributing to the writing, coordination, review, and maintenance of the Risk Management Standard Operating Procedures (SOPs) and associated documents.
Key Responsibilities:
- Conduct risk reviews and escalate findings, as appropriate, to the QRM team
- Track the status of risk mitigation actions through to completion
- Facilitate planning, execution, and completion of risk assessments by providing guidance to cross-functional team members
- Responsible for maintaining the Bothell Quality Risk Catalog/Registry
- Support the creation, revision, and approval of Quality Risk Management Reports
Requirements:
- A minimum of 5 years of relevant Quality experience in a GMP/FDA regulated environment
- Understanding of Quality Risk Management principles and application within quality systems
- Strong technical writing skill set and ability to critically review reports while effectively expressing Quality principles
- Quality and continuous improvement
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
-
Quality Risk Management Specialist
4 days ago
Bothell, Washington, United States Omni Inclusive Full timeJob Title:Quality Risk Management SpecialistJob Summary:We are seeking a highly skilled Quality Risk Management Specialist to join our team at Omni Inclusive. The successful candidate will be responsible for maintaining the Quality risk management program at our manufacturing facility, promoting self-identification of risk areas and implementation of risk...
-
Quality Risk Management Specialist
3 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeJob Title:Quality Risk Management SpecialistJob Summary:We are seeking a highly skilled Quality Risk Management Specialist to join our team at Omni Inclusive. The successful candidate will be responsible for maintaining the Quality risk management program at our manufacturing facility, promoting self-identification of risk areas and implementation of risk...
-
Quality Risk Management Specialist
7 hours ago
Bothell, Washington, United States Katalyst Healthcares and Life Sciences Full timeJob Summary:We are seeking a highly skilled Quality Risk Management Specialist to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for maintaining the Quality risk management program at our manufacturing facility, promoting self-identification of risk areas and implementation of risk mitigation measures...
-
Lead Cybersecurity Risk Manager
3 weeks ago
Bothell, Washington, United States AlienVault Full timeJob OverviewAs a key member of our Chief Security Office, you will play a critical role in ensuring the security and integrity of our technological infrastructure. Your expertise in cybersecurity and risk management will be instrumental in identifying and mitigating potential threats, and in developing and implementing effective risk management...
-
Quality Assurance Specialist
3 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeJob 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,...
-
Senior Design Quality Assurance Specialist
2 weeks ago
Bothell, Washington, United States Philips North America Full timeAbout the RoleWe are seeking a highly skilled Senior Design Quality Engineer to join our team at Philips North America. As a key member of our quality transformation team, you will be responsible for overseeing system and hardware quality and safety risk management throughout the product life cycle.Your primary focus will be on ensuring that all design...
-
Quality Engineering Manager
4 weeks ago
Bothell, Washington, United States Pikemann LLC Full timeQuality Engineering ManagerPikemann LLC is seeking a seasoned Quality Engineering Manager to lead our team in providing quality engineering leadership in direct support of medical device product development and production operations.Responsibilities:Establish goals, provide work direction, manage performance, and develop talent for the team of Quality...
-
Quality Assurance Specialist
2 weeks ago
Bothell, Washington, United States AtWork Group Full timeJob 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...
-
IT Risk and Vulnerability Specialist
19 hours ago
Bothell, Washington, United States Verathon Full timeJob SummaryThe Systems Administrator III, focusing on IT Risk and Vulnerability, is responsible for providing strategic technical advice and solutions to departmental leadership, with a strong focus on IT risk and vulnerability remediation.Key ResponsibilitiesMaintain and oversee backup systems, ensuring backups complete successfully and addressing any...
-
Quality Assurance Specialist
3 days ago
Bothell, Washington, United States Omni Inclusive Full timeJob 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: ...
-
Quality Assurance Operations Specialist
4 days ago
Bothell, Washington, United States Omni Inclusive Full timeJob 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...
-
Senior Design Quality Assurance Specialist
3 weeks ago
Bothell, Washington, United States Philips North America Full timeAbout the RoleWe are seeking a highly skilled Senior Design Quality Engineer to join our team at Philips North America. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met throughout the product life cycle.Key ResponsibilitiesProvide independent oversight of the design input process, design V&V...
-
Quality Assurance Specialist
4 days ago
Bothell, Washington, United States Omni Inclusive Full timeJob 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...
-
Senior Quality Assurance Specialist
20 hours ago
Bothell, Washington, United States Insight Global Full timeJob 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...
-
Quality Assurance Specialist
4 days ago
Bothell, Washington, United States Omni Inclusive Full timeJob 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,...
-
Quality Assurance Document Control Specialist
4 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Document Control Specialist to support our cGMP Document Control operations. The successful candidate will be responsible for receiving and reconciling GMP records, managing scanning and archival processes, and ensuring compliance with FDA regulations.Key ResponsibilitiesOrganize and maintain cGXP...
-
Quality Control Specialist
3 weeks ago
Bothell, Washington, United States Actalent Full timeJob Title: Quality Control SpecialistAbout the RoleThe Quality Control Specialist will play a critical role in supporting drug product lot release and in-process testing within a cGMP environment. This position requires a strong analytical mindset and ability to work in a high-paced team environment.Key ResponsibilitiesSupport cGMP lot release and in-process...
-
Quality Control Specialist
4 weeks ago
Bothell, Washington, United States Actalent Full timeJob Title: Quality Control SpecialistAbout the RoleThe Quality Control Specialist will play a critical role in supporting drug product lot release and in-process testing within a cGMP environment. This position requires a strong analytical mindset and ability to work in a high-paced team environment.Key ResponsibilitiesSupport cGMP lot release and in-process...
-
Bothell, Washington, United States Omni Inclusive Full timeJob 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...
-
BSA Compliance Officer
3 days ago
Bothell, Washington, United States Mbanq Full timeAbout the RoleThe BSA Compliance Officer plays a critical role in ensuring Mbanq and its clients comply with various BSA/AML/CIP/OFAC requirements. This position is responsible for developing, implementing, and maintaining a BSA/AML framework, systems, and processes to ensure ongoing compliance.Key Responsibilities:Maintain current knowledge of the Bank...