Katalyst CRO
Quality Assurance / Quality Operations Executive
Katalyst CRO, Morris Plains, New Jersey, us, 07950
Quality Assurance / Quality Operations Executive
We are looking for a Quality Operations QA Specialist to support daily quality assurance activities at our client site in Morris Plains, NJ. The candidate will ensure that manufacturing, packaging, and testing operations comply with cGMP and company quality standards.
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 GMP, FDA, and quality systems.
Good communication and documentation skills.
Experience with Track Wise, Veeva, or other electronic quality systems.
Knowledge of aseptic or sterile manufacturing processes.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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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 GMP, FDA, and quality systems.
Good communication and documentation skills.
Experience with Track Wise, Veeva, or other electronic quality systems.
Knowledge of aseptic or sterile manufacturing processes.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr