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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Quality Assurance Specialist

Job Description

  • Type: Contract
  • Job #76254

Our client, a leading pharmaceutical company, is hiring a Quality Assurance Specialist consultant on a contract basis.

Work Location

Bothell, WA/Hybrid

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

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