Quality Assurance

Katalyst CRO; Saint Paul (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

TrackWise experience

Veeva experience

Aseptic manufacturing knowledge

Job summary

Katalyst CRO is seeking a Quality Operations QA Specialist to support daily QA activities at a client site in Morris Plains, NJ. The role ensures that manufacturing, packaging, and testing operations comply with cGMP and company quality standards.

You will perform QA reviews, provide quality support across operations, and contribute to investigations and root cause analyses. Strong GMP/FDA knowledge and documentation skills are essential.

Qualifications

• 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.

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.

Skills

QA documentation

Quality systems

GMP/FDA knowledge

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Pharmacy, Chemistry

Tools

TrackWise

Veeva

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.

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.

Nice To Have

• Experience with Track Wise, Veeva, or other electronic quality systems.
• Knowledge of aseptic or sterile manufacturing processes.