Quality Assurance Associate – Supplier Management (Chicago Based)

Role Summary

The Quality Assurance Associate – Supplier Management is responsible for the execution of day-to-day quality activities related to the company-wide quality management system (QMS) with a focus on supplier management ensuring that manufactured products meet quality, regulatory, and compliance standards before release. This role involves meticulous review of batch documentation, adherence to cGMP regulations, and close collaboration with cross-functional teams to support on-time product delivery. This person will also assist in critical departmental activities including but not limited to product complaints, GXP deviations, investigations, CAPA, training, and software validation initiatives.

Responsibilities

• Perform thorough reviews of executed batch records, manufacturing logs, and supporting documentation.
• Identify deviations, discrepancies, or trends and ensure timely resolution and documentation.
• Ensure records comply with internal SOPs, cGMP requirements, and regulatory expectations.
• Assist in final product disposition decisions in collaboration with the Quality Assurance team.
• Assist in identifying, investigating, and documenting deviations or non-conformances.
• Support corrective and preventive actions (CAPA) to resolve issues and prevent recurrence.
• Author and update Quality Policies and procedures as needed.
• Ensure batch release activities align with cGMP, FDA, EMA, and other global regulatory guidelines.
• Develops strong partnerships with CMO‚Äôs to ensure MBRs and EBRs are reviewed thoroughly and efficiently, and meet good manufacturing and documentation practices, product release specifications and compliance.
• Contribute to process improvement initiatives to optimize batch release timelines and data integrity.
• Maintain organized and accurate records to support audit readiness.
• Help ensure all QMS records and documentation are completed in a timely manner and follow established policies, practices, and procedures.
• Liaise with Manufacturing, Quality Control, Supply Chain, and Regulatory Affairs teams to ensure seamless batch release operations.
• Provide quality-related support for production timelines and project milestones.
• Interact with internal customers at various management levels to provide customer service.
• Generates logs, 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

• Associate degree required, Bachelor degree preferred.
• Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company with a focus on batch record review and release preferred.
• Knowledge of cGMP, FDA, and other regulatory guidelines governing manufacturing processes.
• Strong attention to detail and ability to manage competing priorities under tight deadlines.
• Proficient in Microsoft Office Suite, experience with quality management systems (e.g., Veeva Vault) is a plus.
• 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 ‚Äì approximately 10% anticipated.
• 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.
• This is a hybrid role based in Xeris‚Äô Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management‚Äôs discretion.