Senior Quality Auditor - FDA/cGMP Precision

Staffing-Synergies; Edison (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

Staffing Synergies seeks a detail-oriented Quality Auditor to join our team. You’ll ensure that products meet FDA, cGMP, and customer requirements, perform inspections on production lines, and help drive quality across operations.

The role requires 5+ years of GMP/QA experience, strong knowledge of FDA regulations, and excellent communication and teamwork. A High School Diploma or GED is required, with ability to stand for long periods and lift up to 25 lbs.

Qualifications

• 5+ years of GMP/QA experience in a manufacturing environment.
• Strong knowledge of FDA and cGMP regulations.
• Excellent communication, problem-solving, and teamwork skills.

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

QA Experience

GMP Knowledge

FDA Regulations

Communication Skills

Teamwork

Education

High School Diploma or GED

Job description

Staffing Synergies seeks a detail-oriented Quality Auditor to join our team. You’ll ensure that products meet FDA, cGMP, and customer requirements, perform inspections on production lines, and help drive quality across operations.

The role requires 5+ years of GMP/QA experience, strong knowledge of FDA regulations, and excellent communication and teamwork. A High School Diploma or GED is required, with ability to stand for long periods and lift up to 25 lbs.