Quality Engineer – CI & CAPA Leader (cGMP)

EPICUR; Mount Laurel Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

EPICUR Pharma seeks a quality-focused professional to work in a cGMP environment, collaborating with QA, QC, Manufacturing and Distribution to build predictable processes and accelerate new technologies. The role supports continuous improvement and regulatory compliance.

Key duties include serving as SME on cGMP and GDocP, driving lean improvements, managing CAPAs, maintaining validation and equipment records, and ensuring training and SOP development across the site in New Jersey.

Qualifications

• Familiar with GMPs, FDA, ICH, OSHA requirements.
• Experience with QC/QA in pharma or cosmetics.
• Must understand 21 CFR Part 11 and Q7/Q8/Q9/Q10.

Responsibilities

• Serve as SME on cGMP and GDocP.
• Identify improvement opportunities using lean methods.
• Manage CAPAs and calibration/validation records.
• Support training and SOP development across the site.

Skills

GMP knowledge

Quality Assurance

Problem solving

Lean manufacturing

Data analysis

Documentation

Education

BSc in Biology/Chemistry

Tools

Minitab

Excel

Job description

EPICUR Pharma seeks a quality-focused professional to work in a cGMP environment, collaborating with QA, QC, Manufacturing and Distribution to build predictable processes and accelerate new technologies. The role supports continuous improvement and regulatory compliance.

Key duties include serving as SME on cGMP and GDocP, driving lean improvements, managing CAPAs, maintaining validation and equipment records, and ensuring training and SOP development across the site in New Jersey.