Sr QA Associate Specialist
Company: Alpha Consulting Corp.
Location: Bothell
Posted on: May 29, 2023
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Job Description:
SR QA ASSOCIATE SPECIALIST BOTHELL, WA This is a 50/50 on-site
hybrid position. Required Skills: Bachelor's degree or equivalent.
A minimum of three (3) years' experience in a change management
related role, preferably within a Quality Systems team. Experience
in quality management system (change management, deviation, CAPA,
and risk management) processes is preferred. Strong technical
writing skill set and 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 have the ability to build a cross functional network.
Project Description: The QA Associate Specialist, Quality Systems
role is to support the Quality Systems programs at the Jump Client
site located in Bothell, Washington. The primary focus of the QA
Associate Specialist role will serve as a key resource to support
the Change Management program at the Bothell site. This includes
metric gathering, providing site guidance, and administrating site
change control governance meetings. This role will also be
responsible for the change management activities at the Bothell
site. This position works cross-functionally to ensure compliance
with the Cell Therapy global change management program. Additional
activities may be required by the QA Associate Specialist to
support the Quality Systems program at Jump. Working
cross-functionally with teams to provide change management
guidance. Responsible for gathering site metrics including
providing annual APQR change control data. Work with Sr. Manager of
Change Management with providing site training. Draft and review
site change management guidance documents and work practices.
Administrate scheduled and ad-hoc change management governance
meetings including scheduling, building agenda, and issuing meeting
minutes. Facilitate the closure of change control records within
the quality management system. 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: 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, and
review QMS (Quality Management System) documents in the electronic
document management system. Provide communication on the status of
deliverables to customers, management, and stakeholders. This 12+
month position starts ASAP. Please E-MAIL your resume (attachment
to email) with rate and availability to Jacqueline:
jacqueline@alphaconsulting.com ALPHA'S REQUIREMENT #23-00919 MUST
BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
PDN-99253ce0-8122-4696-a632-60b75ccb3cdc
Keywords: Alpha Consulting Corp., Seattle , Sr QA Associate Specialist, Other , Bothell, Washington
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