Job Details

  • ID#48256311
  • Address 98021 , Bothell,


    Bothell USA
  • Job type


  • Hiring Company

    Alpha Consulting Corp.

  • Showed01st January 2023
  • Date31st December 20222022-12-31T00:00:00-0800
  • Deadline01st March 2023
  • Category


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

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