The QA Specialist is a full-time position responsible for providing oversight and guidance for assigned quality systems and compliance activities across the Juno Manufacturing Plant (Jump) located in Bothell, Washington. This includes facilitating quality systems processes, in addition to serving as a key Quality Systems resource for site operations and ensuring compliance with applicable policies, procedures and regulatory requirements. This position also works cross-functionally to ensure relevant process improvements are identified, documented and implemented.
The primary responsibilities of the QA Specialist is to support the Quality Systems programs and implement improvements to mitigate process and / or product risks.
Education; Bachelor's degree or equivalent
A minimum of five (5) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
Experience in quality management system (change management, deviation, CAPA, and risk management) processes
A working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
Experience in leading or participating in projects
Possess working knowledge of Operational Excellence and Lean Six Sigma tools
Primary responsibilities include:
Perform routine and ad hoc Quality System metric reporting and analysis for the local or global site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
Compile, contextualize, evaluate, and present Quality Systems data and metrics for all metric review meetings.
Support the design of effective quality systems, procedures, and processes at site to ensure compliance efficiency
Perform weekly, monthly and quarterly review of systems to identify adverse trends and publish findings into a formal trending report as well as presenting trending results in site forums.
Develop and conduct user training for Quality Systems to site personnel. This includes new hire and routing training for cGMP and site requirements, as well as, assigned Quality and Compliance Systems (i.e. Deviations, CAPAs and Change Control).
Support and train cross functional groups with guidance on deviation management to ensure accurate reporting, investigation, root cause analysis and corrective actions
Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents
Perform ad hoc duties as required in support of all of the Quality Systems at the Jump site including, but not limited to the following:
o Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit.
o Identify and implement continuous improvement opportunities for Quality Systems
o Facilitate cross functional team meetings
o Process, author, review, and approve QMS (Quality Management System) documents in the electronic document management system
o Coordination of data collection for APQR
Provide communication as to the status of deliverables to customers, management and stakeholders.
Must have a strong technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Strong knowledge of cGMPs and regulatory requirements
Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build an internal network.