Overview

The Quality Assurance Associate is responsible for the execution of day-to-day quality activities related to the company-wide quality management system (QMS) with a focus on documentation management in Veeva electronic Document Management System (EDMS), document and product change control. This person will also assist in critical departmental activities including but not limited to product complaints, GXP deviations, investigations, CAPA, management review, training, and software validation initiatives. This person will work with cross-functional teams to develop, implement, and maintain the Quality Management System (QMS) which will support the realization of product quality from development through commercialization.

Responsibilities

• Manage GXP central filing system
• Provide System Administrator support for Veeva EQMS & EDMS
• Facilitates the full life cycle of documents (including but not limited to SOPs, Batch Records, Protocols, Reports, Specifications, etc.) by functioning as workflow coordinator in EDMS
• Author and update document control and training policies and procedures as needed
• Collaborate with the business to ensure that GXP documentation is appropriately and logically filed to ensure retrievability
• Work with Department management to assign personnel and training materials to the appropriate Job Roles/curricula in Veeva
• Support Quality Control data entry processes
• Review, edit and format documents, maintain document properties (metadata), monitor document status and approval notifications, distributions, and archiving.
• With assistance, provide day-to-day support of the EDMS and EQMS, and operational controls to maintain the validated state (compliance with 21 CFR Part 11).
• Help ensure all QMS records and documentation are completed in a timely manner and follow established policies, practices, and procedures
• Work with department leadership in the product change control, complaints and deviations processes.
• Ensure that metrics and data pertaining to performance of QMS are maintained and provide regular updates and status reports to Quality Leadership and other stakeholders
• Perform end-user training for new users of the EDMS and EQMS
• Interact with internal customers at various management levels to provide customer service
• Generates metrics and trend reports, as required
• Provide support for internal and external/regulatory audits and inspections
• Provide quality support for cross-functional initiatives and projects
• All other duties as assigned.

Qualifications

• Bachelor’s degree preferred
• Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.
• Advanced computer capabilities including all MS Office products
• Competencies: Adaptability, Project Management, Problem Solving, Critical Thinking, Self-Starter, Quality-driven, Written & Verbal Communication skills, Organizational skills, Teamwork & Collaboration, Interpersonal skills

Working Conditions

• Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel – approximately 10% anticipated.
• This role is based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management’s discretion.
• Some of the work performed is in a typical office environment and includes long periods of sitting at a desk as well as frequent usage of hands and computer.
• This position requires moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting (up to 25 lbs), and twisting.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.