Urgent Client Requirement: QA Specialist

Houston, TX, US • Posted 14 hours ago • Updated 14 hours ago
Contract Corp To Corp
Contract W2
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • GMP
  • GDP
  • Pharma
  • biopharmaceutical
  • cGMP
  • Validation

Summary

Role: QA Specialist
Duration: 6-12 Months+
Location: Houston, TX (
5 days onsite--Sunday to Thursday 11 pm 8 am)

Note: This job req is for a third (night) shift role: Sunday to Thursday 11 pm 8 am

The QA Specialist Level II-Quality Operations represents the QA department ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem-solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance.

  • Verify the company s compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate.
  • provide oversight for compliance of CAPA and minor deviations.
  • Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
  • Support activities that involve QA presence on the floor.
  • Review Master Batch Records (MBR) and supporting documents to support batch disposition. Perform review/release of Buffer/ media as needed.
  • Perform other duties as assigned.
  • Experience with regulations (US, EU, and other)
  • Experience in a biopharmaceutical manufacturing environment
  • Experience in equipment/facilities/utilities validation activities
  • Strong experience in GDP

Best Regards
Mohd Suhaib
Cardinal Integrated Technologies
Direct:
Ph: Ext 329

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10121181
  • Position Id: 8924456
  • Posted 14 hours ago
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