Quality Assurance - Senior Specialist

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 (Position Summary):

• 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 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:

• 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, 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.

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/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 team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
• Partners with stakeholders to ensures 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
• Uses both soft-skills and technical skills to drive the deviation and CAPA processes:
• Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
• Seeks to understand, demonstrates humility, and shows curiosity for learning Completes deviations that are thorough, accurate, and complete
• Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
• Understands appropriate assignment of classifications and requirements for each
• Understands the importance and impact of lot association within deviations and the relation to product disposition
• Partners to assist cross-functional teams on department-specific trend deviations to:
• Assist with assessing trend details to ensure accuracy and alignment across the team
• Participate in in-depth root cause analysis to determine additional process and system failure modes
• Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
• Determine if previous identified CAPA are sufficient to reduce the trend by defined targets
• Maintains and routinely communicates an up-to-date dashboard of department specific CAPA to show status, escalate issues, provide mitigation plans, and request additional support
• Understands appropriate assignment of classifications and requirements for each:
• Understands multiple RCA tools and when, where, and how to apply them
• Utilizes good technical writing skills
• Participates on GEMBAs or process improvement projects to identify failure modes and seek further understanding of the deviations when needed
• Participate in deviation governance teams, projects, and other initiatives. Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
• Review deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs). Ensures the necessary data to support containment activities and impact assessments have been provided
• Ensures all necessary supporting evidence is attached to the electronic deviation and that all attachments are referenced in the record
• Ensures investigations and root cause analyses are commensurate to the event being investigated
• Understands multiple RCA tools and when, where, and how they should be applied
• Reviews deviation reports for good technical writing skills
• actively coaches and mentors’ investigators through the review and approval processes
• Act as QA Subject Matter Expert (SME) and support cross functional groups on no impact deviation events and development of corresponding corrective and preventive actions as applicable.
• Support internal and external audits, including documenting observations and may oversee implementation of corresponding CAPAs (Corrective and Preventative Action) as applicable.
• Perform quality review and approval of standard operating procedures as applicable.
• Train and mentor junior associates.

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, including the ability to make and promptly respond to audible cues and warnings.
• May Work in areas that may have strong magnets.
• May work in areas with exposure to vapor phase liquid nitrogen and other chemicals.
• Must be able to gown per requirements to enter manufacturing space.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to, safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees holding this position will be required to perform any other job-related duties as requested by management.