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 SOPs, FDA, and quality systems.
Good communication and documentation skills.
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.
Benefits
Opportunity to work at a client site in Morris Plains, NJ.
Exposure to diverse quality assurance activities in a dynamic environment.
Potential for career growth within the pharma and healthcare sectors.
Collaborative work culture with support from experienced professionals.
Full Job Description
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.
Required Skills and Experience:
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 sop, FDA, and quality systems.
