Quality Assurance Associate

Job Locations US-IL-Chicago
ID
2022-1565
Category
Quality Assurance
Type
Full-Time

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 product batch release, document and change control, including performing quality action items.

Responsibilities

  • Primary review of EBR (Executed Batch Record) for intermediate drug products, finished drug products and devices.
  • Assist with batch disposition documentation and activities.
  • Ensure product release documentation properly filed in Veeva.
  • Develops strong partnerships with CMO’s to ensure MBRs and EBRs are reviewed thoroughly and efficiently, and meet good manufacturing and documentation practices, product release specifications and compliance.
  • Assists lead auditor during supplier and internal audits.
  • Manage population of data collection spreadsheets for Annual Product Review process.
  • Assignment of product lot numbers.
  • Provides QA support to exception investigation and resolution.
  • Works closely with Supply Chain to review component receipts at 3PL and recommend disposition.
  • Reviews new MBR (Master Batch Record) and proposed changes to MBR (Master Batch Record), including the assignment of lot numbers and verifying labeling content.
  • Supports Quality Manager(s) and the QA and QC teams in management and coordination of the QMS activities.
  • Collaborates with the Quality Control team to manage the workflow of specifications and Safety Data Sheets (SDS) review and approvals.
  • Participates in PAI inspections as needed.
  • Travels as needed to be “person-in-plant” for manufacturing and validation runs.
  • Supports supplier selection and qualification processes, including due diligence and auditing.

Qualifications

  • Associate’s degree required, Bachelor’s degree preferred.
  • Minimum of two (2) years Quality Assurance experience in a pharmaceutical and/or biotech company.
  • Proficient with use of Microsoft Word, PDF Pro software, and Excel. Ability to create controlled forms, and merge old format templates into new formats.
  • Experience with electronic document management systems.
  • Competencies: Results-oriented, Verbal and Written Communication skills, Attention to Detail, Organizational skills, Project and Time Management, Independent Judgement, Teamwork and Collaboration
  • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Travel up to 10%.

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.

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