Quality Assurance Specialist
Company: Eclaro
Location: Bothell
Posted on: May 28, 2023
|
|
Job Description:
Quality Assurance SpecialistJob Number: 23-01254 Be part of a
company that delivers life-changing healthcare solutions. Eclaro is
looking for a Quality Assurance Specialist for our client in
Bothell, WA. Eclaro's client is a leader in the Biopharmaceutical
Industry, providing quality, innovative and affordable medicines
that make a difference in the lives of patients all over the world.
If you're up to the challenge, then take a chance at this rewarding
opportunity! Position Overview: Support the Quality Systems
programs at the Client site. 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. Works cross-functionally to ensure
compliance with the Cell Therapy global change management program.
This role will also be responsible for the change management
activities at the site. Additional activities may be required by
the QA Associate Specialist to support the Quality Systems program
at client's. Responsibilities: Working cross-functionally with
teams to provide change management guidance Responsible for
gathering site metrics including providing annual APQR change
control data Work with Senior 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 client's 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.Qualifications: Bachelors degree or equivalent (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 preferredSkills: 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 the ability to build
a cross functional network.If hired, you will enjoy the following
Eclaro Benefits: 401k Retirement Savings Plan administered by
Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility
to purchase Medical, Dental & Vision Insurance through Eclaro If
interested, you may contact: Larah Beaniza larah.robledo@eclaro.com
3322094549 Equal Opportunity Employer: Eclaro values diversity and
does not discriminate based on Race, Color, Religion, Sex, Sexual
Orientation, Gender Identity, National Origin, Age, Genetic
Information, Disability, Protected Veteran Status, or any other
legally protected group
status.PDN-99253cea-5816-4d9f-8e07-e95576377c56
Keywords: Eclaro, Seattle , Quality Assurance Specialist, Other , Bothell, Washington
Click
here to apply!
|