QA Specialist II Job at Astrix, Dallas, TX

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  • Astrix
  • Dallas, TX

Job Description

Rapidly growing Biotech Manufacturer is seeking a QA Specialist II near Dallas, TX! This is a great opportunity to work with an innovative company that has cutting-edge technology!

QA Specialist II

Terms : C2H 6mo conversion

Pay : $24-$28/hr DOE

Schedule : Variable - start times could vary

QA Specialist II – Sterile Manufacturing

Step into a key quality role that keeps life-saving products safe and compliant. As a QA Specialist II , you'll be the quality gatekeeper for GMP manufacturing—reviewing critical documentation, inspecting materials, and ensuring every step meets strict regulatory standards. Your focus: supporting sterile operations, driving compliance, and fueling continuous improvement.

What You’ll Do:

  • Review batch records, raw materials, and packaging docs for compliance
  • Oversee sterile manufacturing areas, including gowning and aseptic technique guidance
  • Perform area releases and inspect GMP equipment/instrumentation documentation
  • Track and close investigations, CAPAs, and change controls
  • Archive essential QA documents and support tech transfer from R&D
  • Help update SOPs and conduct internal audits

What You Bring:

  • Bachelor’s in a scientific/technical field
  • 2–5 years in pharma or related industry, with 2+ in sterile manufacturing preferred
  • Strong GMP knowledge and experience reviewing batch records
  • Skilled in SOP writing and document systems
  • Hands-on experience with aseptic training, internal audits, and tech transfer
  • Familiarity with CAPA, change control, and eQMS tools

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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