Katalyst Healthcares and Life Sciences
Quality Assurance / Quality Operations Executive
Katalyst Healthcares and Life Sciences, Morris Plains, New Jersey, us, 07950
Job Description:
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. 3-5 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.
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. 3-5 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.