Quality Assurance Associate

Job Title: Quality Assurance Associate
Location: Northbrook, IL 60062
Contract: 12 Months (Possibility of Extension)

Pay Range: $43.91 - $60 hour. on W2
 
Work Schedule:

• 32 hours per week
• 4 days per week

 
Essential Job Duties:
Provides Good Distribution Practice (GDP) Quality Assurance support to the Lead, Quality Assurance, US GDP, by assisting in the following activities:

• Annual Supplier Qualification
  • Support annual review and qualification processes for GDP suppliers.
• Support 3PL Activities
  • Review and approve work instructions.
  • Review and approve nonconformance and incident reports.
  • Approve quality discrepancy reports (nonconformance approvals).
  • Provide GDP QA input for Business Review Management.
• Upstream Supply Chain Activities (product shipped from plants/suppliers to Client 3PL)
  • Temperature Excursion Management: Approve temperature deviations for shipments sent to 3PL; update temperature excursion handling process.
  • Product Damage Management: Approve deviations for product damage; update product damage handling process.
• Document Management
  • Manage and archive GDP QA documents in Veeva/eQMS.
• Additional GDP Support
  • Provide support with any other GDP-related activities as required.

 
Required Qualifications:

• Education: BA/BS degree in a science-related field.
• Experience: Minimum 5 years of pharmaceutical industry experience, with at least 3 years in Quality Assurance.
• Knowledge:
  • Strong understanding of GDP and other relevant regulatory requirements.
  • Broad knowledge of quality principles and current industry trends.
• Skills:
  • Effective written and oral communication, interpersonal, facilitation, and influencing skills.
  • Ability to work effectively across cross-functional groups and with external stakeholders.
  • Self-starter, proactive, and capable of managing departmental resources to achieve daily objectives.

 
Preferred Qualifications:

• Experience with GxP documentation systems such as Trackwise (Digital), Veeva, and SAP systems.
• Direct experience in a Quality Assurance function, preferably within GDP operations.
• Working knowledge of global industry standards and regulatory requirements (e.g., US, EU, Japan).
• Proficiency with Microsoft Excel, Word, and PowerPoint.