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QA Specialist

Company: Analysts
Location: Bothell
Posted on: January 12, 2021

Job Description:

Title : QA Specialist Location: Bothell, WADuration: 12 months contractDescription:This role is part of the site's Quality Systems team and leads the efforts to review, analyze, revise, and report site-specific metrics and key performance indicators. This individual works cross-functionally and within the network to support continual improvement initiatives and to ensure alignment with applicable policies and standards.Primary responsibilities include:With Business Process Managers, prepare metrics and interpret the data in preparation for Quality Management Review (QMR). This may require the use of relational databases and / or reporting tools to collate and analyze quality data.Develop and / or improve routine and ad hoc Quality Systems metric reporting for trending, performance deficiencies and conformance to KPIs.Evaluate data to identify opportunities for operational efficiencies, develop improvement plan and deploy across the site.Partner with functional areas in identifying and/or harmonizing metrics that support routine operations of the Quality Management System.Support internal and external audits and regulatory inspections through gathering, analyzing, and formatting of data.Support corporate and site-level requests for compliance and business dataCollaborate and contribute to the writing, coordination, review, and maintenance of Standard Operating Procedures (SOPs) and / or other procedures.Collaborate with Quality Systems functions to ensure compliance with corporate and site procedures and policies.Facilitates the implementation of IT tools that drive effectiveness and efficiency into the business.Coordinate data gathering to support Annual Product Quality ReviewRequired Qualifications:Strong technical writing skill setInnovative, proactive, and resourcefulQuality and continuous improvement mindsetStrong project planning skills.Strong computer skills with MS Office (e.g. Word, Adobe, Visio, and Excel) and with Quality Systems (e.g. Veeva Document Management System, electronic Quality Management System)Experience interacting with FDA or other regulatory agencies strongly preferredStrong knowledge of cGMPs and domestic regulatory requirementsKnowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, packaging, and labeling, etc.)Education: Bachelor's degree or equivalentExperience A minimum of 5 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment.

Keywords: Analysts, Seattle , QA Specialist, Other , Bothell, Washington

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