QA Documentation Specialist - Austin, United States - Infotree Global Solutions

Infotree Global Solutions
Infotree Global Solutions
Verified Company
Austin, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Responsibilities:


  • Provide QA support on the floor for production
  • Ensure process control measures are in place and followed in product manufacturing
  • Receipt and disposition of incoming apheresis material.
  • Oversee and authorize shipment of final product
  • Verify and ensure timely issuance of production documents and labels
  • Review batchrelated documentation and ensure resolution of issues to release and ship product.
  • Gather and report metrics to measure performance
  • Identify continuous improvement actions
  • Ensure timely resolution and escalation of issues
  • Ensure all productrelated Deviations are initiated, investigated and resolved.
  • Ensure that associated CAPAs are initiated and resolved, as needed.
  • Perform lot closure activities.
  • Ensure approval and timely delivery of final product.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Provide Quality Assurance support resolving material, inprocess product, final product, environmental, facility and equipment manufacturing issues.
  • Perform other duties as assigned

Basic Qualifications:


  • BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
  • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
  • High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
  • Experience with manufacturing investigations, deviations, and CAPA.
  • General knowledge of aseptic manufacturing processes.

Job Type:
Contract


Pay:
$ $21.50 per hour


Schedule:

  • 8 hour shift

Work setting:

  • Inperson

Experience:


  • Batch records and

CAPA:
2 years (required)

  • Pharmaceutical/ Biotechnology industry: 2 years (required)

Ability to Commute:

  • Austin, TX required)

Work Location:
In person
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