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9 Dec 2020

Temporary QA Specialist – Metrics (20-19767)

Axelon Services Corporation – Posted by iris.chen@axelon.com Bothell, Washington, United States

Job Description

Position: Contractor, Quality Systems and Compliance – (Sr QA Specialist – Metrics)
Reports To: Senior Manager, Quality Systems
Location: Bothell, WA

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 data
• Collaborate 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 Review

Required Qualifications:
• Strong technical writing skill set
• Innovative, proactive, and resourceful
• Quality and continuous improvement mindset
• Strong 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 preferred
• Strong knowledge of cGMPs and domestic regulatory requirements
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, packaging, and labeling, etc.)

Education: Bachelor’s degree or equivalent
Experience A minimum of 5 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment.

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 46 days.

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