Sr Qa Associate Specialist

Job Description
SR QA ASSOCIATE SPECIALIST
BOTHELL, W
This is a 50/50 on-site hybrid position.
Required Skills:

• Bachelor's degree or equivalent.
• 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.
• bility 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.
• dditional 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.
• dministrate 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
LPHA'S REQUIREMENT #23-00919
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE