Pharma Quality Engineer: cGMP, Validation & Compliance

Stark Pharma Solutions Inc; Newark (NJ); On-site; USD 90,000 - 125,000; Full time

Job summary

Stark Pharma Solutions Inc in New Jersey seeks an experienced Quality Engineer to support QA, compliance, validation, and quality systems in a pharmaceutical manufacturing environment. You will ensure FDA/cGMP compliance, data integrity, and continual improvement across operations.

Responsibilities include leading deviations, CAPAs, change controls, investigations, and GMP document reviews, while collaborating with Manufacturing, Engineering, Validation, and Regulatory teams to drive inspection

Qualifications

• Bachelor's degree in a technical field and 5+ years in quality engineering/assurance.
• Experience in regulated manufacturing (pharma/biotech/med device) environments.
• Strong knowledge of quality systems, deviations, CAPA, change control, investigations, and risk management.

Responsibilities

• Provide quality oversight for manufacturing operations and ensure cGMP/FDA compliance.
• Manage quality system activities: deviations, CAPAs, change controls, non-conformances, risk assessments.
• Lead root cause investigations and implement corrective actions.
• Review/approve manufacturing records, SOPs, validation docs, and GMP records.
• Support equipment qualification (IQ/OQ/PQ), process validation, and validation-related activities.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to resolve issues.
• Analyze quality metrics to identify process improvements and compliance enhancements.
• Support internal audits, supplier quality programs, customer audits, and regulatory inspections.
• Ensure compliance with 21 CFR Part 210/211, ICH, GDP, and ALCOA+ data integrity.

Skills

cdGMP knowledge

FDA requirements

Quality systems

CAPA management

Investigations

Process validation

Root cause analysis

Data integrity

Cross-functional collaboration

Technical writing

Education

Bachelor's Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or related

Job description

Stark Pharma Solutions Inc in New Jersey seeks an experienced Quality Engineer to support QA, compliance, validation, and quality systems in a pharmaceutical manufacturing environment. You will ensure FDA/cGMP compliance, data integrity, and continual improvement across operations.

Responsibilities include leading deviations, CAPAs, change controls, investigations, and GMP document reviews, while collaborating with Manufacturing, Engineering, Validation, and Regulatory teams to drive inspection