Quality Assurance

Katalyst-Healthcares-; Saint Paul (MN); On-site; USD 70,000 - 95,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Operations – QA Specialist to support daily QA activities at our client site. You will ensure manufacturing, packaging, and testing operations comply with cGMP and internal quality standards.

Responsibilities include QA review of batch records, deviations, CAPAs, and change controls, and supporting audits, investigations, and documentation. A life sciences degree with 3–5 years in QA or quality operations is required.

Qualifications

• 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.

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

Quality Assurance

Documentation

Communication

Regulatory Knowledge

Education

Bachelor's degree in Life Sciences or related field

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.


• 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.

Nice to Have:

• Experience with Track Wise, Veeva, or other electronic quality systems.


• Knowledge of aseptic or sterile manufacturing processes.