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Quality Assurance Specialist

Posted 18 days ago

  • Expiry Date: 09 December 2022
  • Referral: 219604@accuick.com

Job Description:

  • The QA Specialist is a full-time position responsible for providing oversight and guidance for assigned quality systems and compliance activities across the Manufacturing Plant 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; Bachelors degree or equivalent.

Basic Qualifications:

  • 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.

  • 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.

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613