Metrics QA Specialist

Company: Alpha Consulting
Location: Bothell
Posted on: January 15, 2021

Job Description:

METRICS QA SPECIALISTBOTHELL, WAProject Description: 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.* 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.)Required Skills:* Education: Bachelor's degree or equivalent* Experience A minimum of 5 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment. This 12+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.com ALPHA'S REQUIREMENT #20-02048MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZRSDL2017

Keywords: Alpha Consulting, Seattle , Metrics QA Specialist, Other , Bothell, Washington