Our client, a leading pharmaceutical company, is hiring a Quality Assurance Specialist consultant on a contract basis.
This is a 50/50 on-site hybrid position.
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.
Major duties and 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 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:
o Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit.
o Identify and implement continuous improvement opportunities for Quality Systems
o Facilitate cross-functional team meetings
o 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.
Bachelors degree or equivalent
Experience / Knowledge Desired:
• 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 the ability to build a cross functional network.
Pay Range: $80-$85