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