Quality Systems & Compliance Specialist

Englewood Lab; Totowa (NJ); On-site; USD 50,000 - 60,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) with match

Paid Time Off

Job summary

Englewood Lab in Totowa, NJ, seeks a QA Systems & Compliance Associate to support quality systems, audits, CAPA, and data integrity across the site. The role collaborates with QA/QC, Manufacturing, R&D and Regulatory Affairs to ensure cGMP compliance and continuous improvement.

The position emphasizes audit readiness, supplier qualification, and cross-functional problem solving, with a strong emphasis on FDA and ISO standards.

Qualifications

• Bachelor’s degree in a scientific, quality-related, engineering, or related discipline.
• 2–4 years of experience in quality engineering, investigations, CAPA, auditing, or related functions.
• Experience with cGMP, ISO 22716, FDA expectations is preferred.
• Experience planning or conducting internal audits and supporting external audits is preferred.
• Familiarity with data integrity concepts and calibration/metrology.
• QA certifications (e.g., CQA/CQE) are a plus.

Responsibilities

• Plan internal quality system and process audits against cGMP/ISO/customer requirements.
• Prepare audit plans, checklists, reports, and classify findings by risk.
• Track corrective actions through closure and verify effectiveness.
• Support customer, supplier, and regulatory audits including FDA inspections.
• Lead CAPA investigations and root cause analyses; manage action plans.
• Support validation/qualification activities and data integrity controls.

Skills

Auditing

Data integrity

CAPA

Quality systems

GxP

Regulatory compliance

Root cause analysis

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree in a scientific/quality-related discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

Englewood Lab in Totowa, NJ, seeks a QA Systems & Compliance Associate to support quality systems, audits, CAPA, and data integrity across the site. The role collaborates with QA/QC, Manufacturing, R&D and Regulatory Affairs to ensure cGMP compliance and continuous improvement.

The position emphasizes audit readiness, supplier qualification, and cross-functional problem solving, with a strong emphasis on FDA and ISO standards.