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.