Jobs · Quality Assurance · New Jersey

Quality Assurance / Quality Operations Executive

Katalyst CRO · Morris Plains, NJ · 8 mo ago
On-siteQuality AssuranceContract

Responsibilities

  • Perform QA review of batch records, deviations, CAPAs, and change controls.
  • Provide quality support to manufacturing, packaging, and laboratory operations.
  • Ensure compliance with GMP, FDA, and company quality policies.
  • Participate in investigations and support root cause analysis for quality issues.
  • Review and approve SOPs, validation protocols, and reports.
  • Support internal and external audits and inspection readiness.
  • Maintain accurate QA documentation and records.

Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
  • 35+ years of experience in Quality Assurance or Quality Operations.
  • Background in Pharma or Healthcare industry is required.
  • Strong understanding of SOP, FDA, and quality systems.
  • Good communication and documentation skills.

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