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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 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

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