QA Specialist

QA SPECIALIST BOTHELL, WA Project Description:

• 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 are to support the Quality Systems programs and implement improvements to mitigate process and / or product risks.

• 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 the Quality Systems at the Jump site including, but not limited to the following:
  • Support internal and external audits and regulatory inspections. This may require data gathering, interviewing, or escorting auditors during the audit.
  • Identify and implement continuous improvement opportunities for Quality Systems
  • Facilitate cross functional team meetings
  • Process, author, review, and approve QMS (Quality Management System) documents in the electronic document management system
  • Coordination of data collection for APQR
• Provide communication as to the status of deliverables to customers, management, and stakeholders.

Required Skills:

• 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
• 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.

This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Malika: ALPHA'S REQUIREMENT # 22-03069 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE