Quality Assurance Specialist I

Title: Quality Assurance Specialist I

Description:

The primary responsibility of the Quality Assurance Specialist I will be to assist in the continuing development and maintenance of the organization’s Quality Management System, including incident management, audit management (external and internal), systems validation, and working in the electronic QMS (eQMS).   A significant amount of time will be spent in the eQMS performing system administration tasks. The QA Specialist I will work with other members of the Quality Assurance team to ensure that the QMS and eQMS is properly managed and improved, that all QA deliverables are completed as required, and that the QA team is able to effectively manage its various roles and responsibilities within the organization as a whole. 

Major duties and responsibilities:

• Assist in cross office compliance efforts
• Work with office leaders to define compliance needs
• Conduct assessments (IAPs) and/or Gap Assessments
• Build, enforce and improve QMS infrastructure where required
• Regular meetings with QA personnel in Amherst and other offices
• Ensure success of current quality initiatives by working with a cross office team of QA experts
• Assist with incident management, CAPA management, and implementation of electronic quality management system (eQMS)
• Performs system administrator duties in the eQMS
• Conduct internal audits and recommend procedure improvements as needed
• Conduct investigations into incidents of noncompliance
• Track, monitor, and gather metrics from corrective and preventative action activities
• Provide support to other QA team members and Project Leads
• Assist with the eQMS quality software validation efforts, including preparing the required documentation and testing efforts
• Maintain knowledge and expertise in regulations, trends, and industry best practices affecting the clinical research good clinical practices (GCP) environment
• Train other office staff on the organization’s eQMS and associated policies and procedures
• Assist in writing policies and procedures for the Quality Department
• Assist with technical writing activities as needed
• Create and revise documentation related to company or department policies and procedures, internal workflows, and reference guides
• Review, proofread, and edit business correspondence (emails, letters, newsletters, or other documents) as requested
• Assist as necessary in business development initiatives

Reports to: Quality Assurance Manager

Controls over position:  The Quality Assurance Specialist I performs primary tasks at the direction of the Quality Assurance Manager, the Director of Laboratory Data Management System, and the Compliance Committee. The Quality Assurance Specialist I ensures that duties are executed in compliance with applicable SOPs or work instructions.

Required qualifications: