TechDigital Group
Quality Assurance Operations - Senior Specialist, Quality Assurance
TechDigital Group, Bothell, Washington, United States, 98021
Job Title: Senior Specialist, Quality Assurance
Location: 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. Experience with use of complex Root Cause Analysis (RCA) tools and methodologies, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. PURPOSE AND SCOPE OF POSITION: The Quality Assurance (QA) Senior Specialist, Deviation Facilitator position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump) and is an individual contributor role responsible for leading/facilitating triages, deviation approvals, and CAPA records through the electronic quality record management system. This role focuses on deviation triage, initiation, and classification of events at the Bothell Manufacturing Plant (JuMP) in Bothell, WA. This position will be responsible for operating cross-functionally, facilitating/leading triages, reviewing necessary data and information associated with the deviations with no impact and determining the associated corrective action to prevent the deviation from recurring. This person will be a key player for the QA Ops department and be a champion for quality priority principles and compliance within the Jump organization. This role directly supports Jump's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment. QUALIFICATION REQUIREMENTS: Education: Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required. Experience: 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Minimum of 4 years working within quality systems managing deviations and CAPA. Experience with use of complex Root Cause Analysis (RCA) tools and methodologies is a plus. Demonstrate excellence in written and verbal communication. Innovative, proactive, and resourceful; committed to quality and continuous improvement. ROLES AND RESPONSIBILITIES: Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date. Leads/facilitates triage, deviation process, investigations, and No Impact deviation closure of records, CAPA, change controls, process transfers, and other business drivers in a compliant manner. Partners with their investigation team/cross-functional team to approve No Impact Deviations in a timely manner to support RFT. Partners with stakeholders to ensure smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure. Participates on GEMBAs or process improvement projects to identify failure modes and seek further understanding of the deviations when needed. WORKING CONDITIONS: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management. #J-18808-Ljbffr
Location: 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. Experience with use of complex Root Cause Analysis (RCA) tools and methodologies, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. PURPOSE AND SCOPE OF POSITION: The Quality Assurance (QA) Senior Specialist, Deviation Facilitator position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump) and is an individual contributor role responsible for leading/facilitating triages, deviation approvals, and CAPA records through the electronic quality record management system. This role focuses on deviation triage, initiation, and classification of events at the Bothell Manufacturing Plant (JuMP) in Bothell, WA. This position will be responsible for operating cross-functionally, facilitating/leading triages, reviewing necessary data and information associated with the deviations with no impact and determining the associated corrective action to prevent the deviation from recurring. This person will be a key player for the QA Ops department and be a champion for quality priority principles and compliance within the Jump organization. This role directly supports Jump's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment. QUALIFICATION REQUIREMENTS: Education: Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required. Experience: 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Minimum of 4 years working within quality systems managing deviations and CAPA. Experience with use of complex Root Cause Analysis (RCA) tools and methodologies is a plus. Demonstrate excellence in written and verbal communication. Innovative, proactive, and resourceful; committed to quality and continuous improvement. ROLES AND RESPONSIBILITIES: Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date. Leads/facilitates triage, deviation process, investigations, and No Impact deviation closure of records, CAPA, change controls, process transfers, and other business drivers in a compliant manner. Partners with their investigation team/cross-functional team to approve No Impact Deviations in a timely manner to support RFT. Partners with stakeholders to ensure smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure. Participates on GEMBAs or process improvement projects to identify failure modes and seek further understanding of the deviations when needed. WORKING CONDITIONS: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management. #J-18808-Ljbffr