Quality - Quality Assurance Specialist

Quality Assurance Specialist

Location:

Bothell, WA
* 100% Onsite

Schedule:

Wed - Sat: 1:30pm
-12:00am

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Skills:

3-5 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. Demonstrate excellence in written and verbal communication. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

The Quality Assurance (QA) Specialist, 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 at the Juno Manufacturing Plant (Jump) located in Bothell, WA. 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 determine the associated corrective action to prevent the deviation from recurring and ensures any written deviations/investigations report, if applicable, contains the technical merit and completeness according to regulatory expectations. 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.

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:

3-5 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, research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus. Demonstrate excellence in written and verbal communication. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. Innovative, proactive, and resourceful; committed to quality and continuous improvement. Ability to anticipate and mitigate challenges.

Strong computer skills with Word and Excel and other electronic manufacturing systems. Detail oriented team player with effective planning, organization, time-management, and execution skills. Proven experience working on teams and an individual contributor where combined contribution, collaboration, and results were expected. Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them.

Extensive experience in Quality Assurance processes. Ability to work in a high paced team environment. Strong written and verbal skills.

Licenses/Certifications:

N/A

Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date Leads/facilitate triage, deviation process, investigations (as applicable), and No Impact deviation closure of records, CAPA (Corrective and Preventative Action), change controls, process transfers, and other business drivers are supported in a compliant manner. Immediately upon assignment of a deviation, partners with their investigation team/cross-functional team approve No Impact Deviations in a timely manner to support RFT.

May partner with (QA Reviewer/ Approver, SMEs (Subject Matter Experts) [subject matter experts], and necessary stakeholders) for deviations with higher classification to help on definition and alignment of the investigation plan, required data, and timing for completion as applicable. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA. Partnering with functional areas to help drive on-time phase completion, including No Impact deviation closures, RCA Assessment approvals, and participates in cross functional project teams.

When CAPA are needed, partners/facilitates the investigation / CAPA…