QA Specialist

2 weeks ago


El Segundo, United States TekWissen LLC Full time
Job DescriptionJob DescriptionOverview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. Position: QA Specialist - III Location: El Segundo, CA 90245 Duration: 12 Months Job Type: Contract Work Type: Onsite
Description:
  • This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • This position is located at Client site and reports into the Sr. QA Manager, Quality Operations.
Responsibilities
  • Review batch-related documentation and ensure resolution of issues to release product.
  • Perform comprehensive quality review of batches for disposition.
  • Ensure process control measures are in place and followed in product manufacturing
  • Ensure all product-related Deviations are initiated, investigated and resolved.
  • Ensure that associated CAPAs are initiated and resolved, as needed.
  • Generate and update procedures, forms and other documents.
  • Represent Disposition or QA Ops at plant and multi-site scheduling meetings
  • Provide QA representation at multi-site disposition meetings
  • Provide QA representation on projects and at team meetings
  • Maintain metrics related to product disposition in support of the Management Review and for continuous improvement
  • Support and participate in inspections and audits
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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