Quality Auditor - GMP/FDA Compliance & Real-Time QA

Staffing Synergies; Edison (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Staffing Synergies is seeking a detail-oriented Quality Auditor to ensure products meet quality, safety, and compliance standards on the manufacturing floor. You will participate in inspections, audits, and record-keeping to uphold stringent quality controls.

The role requires 5+ years of GMP/QA experience, strong FDA/cGMP knowledge, and the ability to work independently in a fast-paced environment while maintaining meticulous documentation and collaboration with Production teams.

Qualifications

• 5+ years GMP/QA experience in a manufacturing environment.
• Strong knowledge of FDA and cGMP regulations.
• Excellent communication, problem-solving, and teamwork skills.
• Ability to work independently, manage multiple tasks, and adapt to changing priorities.
• High School Diploma or GED required.

Responsibilities

• Perform quality inspections on production lines to ensure compliance with FDA, cGMP, SOPs, and customer requirements.
• Partner with Production and Quality Management to resolve quality issues in real time.
• Conduct inspections, audits, and Acceptance Quality Limits (AQL) checks to verify product integrity.
• Confirm and record date codes, lot numbers, expiration dates, and labeling accuracy.
• Place non-conforming materials in quarantine and document all deviations.
• Monitor batch records, validation protocols, and ensure proper documentation is completed.

Skills

GMP/QA experience

FDA knowledge

cGMP regulations

Quality inspections

Documentation

Teamwork

Independent worker

Education

High School Diploma or GED

Tools

AQL checks

Job description

Staffing Synergies is seeking a detail-oriented Quality Auditor to ensure products meet quality, safety, and compliance standards on the manufacturing floor. You will participate in inspections, audits, and record-keeping to uphold stringent quality controls.

The role requires 5+ years of GMP/QA experience, strong FDA/cGMP knowledge, and the ability to work independently in a fast-paced environment while maintaining meticulous documentation and collaboration with Production teams.