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Associate Director Quality Assurance

Astrix
Indianapolis, IN Full Time
POSTED ON 1/15/2025
AVAILABLE BEFORE 2/9/2025

Join our amazing team! We want to help you continue to succeed and grow in the life sciences industry!

Our Associate Director of Quality Assurance position is a great opportunity to oversee the quality assurance of this manufacturing company with great pay and benefits!


We are looking for a sharp professional that possesses these top 3 skills:

  • 6 Years of progressive QA/QC experience
  • 3 years in a managerial role in a pharmaceutical or regulated industry
  • KPI, CAPA, Change control experience


Pay: $150k-$180k w/ 10% annual bonus

Schedule: 1st shift

Type of Job: Direct Hire

Location: 100% On-site (Indianapolis area)


At this time, Astrix cannot transfer nor sponsor a work Visa for this position.

Relocation assistance is not available for this position.


Associate Director of Quality Assurance Daily Tasks: What you will do:

  • Responsible for the oversight of the QA teams responsible for supporting all production/processing areas.
  • Leads investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation.
  • Responsible for QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports.
  • Contributes in Regulatory/FDA inspections and audits by providing information or obtaining information required by the auditors.
  • Performs review of root-cause analysis and ensures completeness, accuracy and compliance of all documentation.
  • Develops and observes appropriate KPI's for batch documentation review and support of timely batch release.
  • Accountable for the QA department planning, talent development, and budget administration.


Associate Director of Quality Assurance Qualifications/Requirements:

  • Bachelor’s Degree is required
  • 6 Years of progressive QA/QC experience
  • 3 years in a managerial role in a pharmaceutical or regulated industry


We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Salary : $150,000 - $180,000

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