Job description

Quality Assurance Specialist
Job 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 preferred

Skills:

• 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.

Job Type: Contract

Salary: $75.00 - $84.00 per hour

Schedule:

• 10 hour shift
• 8 hour shift

Work Location: On the road

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