Quality Engineer

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

Job Title

Quality Engineer

Location

New Jersey

Duration

Long Term

Position Overview

We are seeking an experienced Quality Engineer to support quality assurance, compliance, validation, and quality systems activities within a pharmaceutical manufacturing environment. This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system management, investigations, validation support, and continuous improvement initiatives across manufacturing operations.

Key Responsibilities

• Provide quality oversight for manufacturing operations and ensure compliance with cGMP regulations, FDA requirements, and company quality standards.
• Manage and support quality system activities, including deviations, CAPAs, change controls, non‑conformances, and risk assessments.
• Lead and participate in root cause investigations and implement corrective and preventive actions.
• Review and approve manufacturing records, SOPs, validation protocols, reports, and GMP documentation.
• Support equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and ongoing process verification activities.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to resolve quality and compliance issues.
• Analyze quality metrics and trends to identify opportunities for 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 guidelines, GDP, and ALCOA+ data integrity principles.
• Promote a culture of quality through training, compliance awareness, and continuous improvement initiatives.

Required Qualifications

• Bachelor's Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, or a related technical discipline.
• 5+ years of Quality Engineering, Quality Assurance, Validation, or related experience.
• Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Strong knowledge of quality systems, including deviations, CAPA management, change control, investigations, and risk management.
• Experience supporting equipment qualification, process validation, and manufacturing quality oversight.
• Understanding of cGMP regulations, FDA requirements, data integrity principles, and inspection readiness activities.
• Strong analytical, problem‑solving, technical writing, and communication skills.
• Ability to work effectively in a cross‑functional team environment.
• Experience supporting regulatory, customer, or third‑party audits is preferred.