Quality Engineer: GMP/ISO-CAPA & Continuous Improvement

Pro Staff; Phillipsburg (NJ); On-site; USD 55,000 - 92,000; Full time

Benefits offered by this job

Medical, dental, vision, and pet 보험

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

Health Savings Account (HSA)

AD&D Insurance

Job summary

Pro Staff is seeking an experienced Quality Engineer for a temporary assignment in Phillipsburg, NJ. The role focuses on quality assurance, regulatory compliance, and continuous improvement within pharmaceutical/biotech/chemical environments.

The Quality Engineer will lead QA initiatives, manage CAPAs, and support cGMP, ISO standards, and FDA compliance while collaborating with cross-functional teams to uphold quality standards.

Qualifications

• Bachelor's degree in Engineering or related field preferred.
• 5 years of Quality Engineering experience.
• Experience in pharmaceutical, biotechnology, or chemical manufacturing environments.
• Strong knowledge of cGMP regulations, ISO standards, quality systems, audits, CAPA, validation, and compliance programs.

Responsibilities

• Lead quality assurance and continuous improvement projects.
• Support regulatory compliance with cGMP, ISO 9000, FDA, ICH Q7, and related quality standards.
• Manage and investigate CAPAs, customer complaints, quality events, validation activities, and process improvements.
• Perform root cause analysis and develop corrective and preventive actions.
• Analyze quality data, identify trends, and recommend process enhancements.
• Coordinate internal, customer, certification, and surveillance audits.
• Collaborate with customers, vendors, and internal teams to resolve quality concerns and ensure compliance.
• Support validation, stability, and statistical process control activities.

Skills

Quality engineering

Quality assurance

Regulatory compliance

Root cause analysis

Analytical skills

Education

Bachelor's degree in Engineering or related field

Job description

Pro Staff is seeking an experienced Quality Engineer for a temporary assignment in Phillipsburg, NJ. The role focuses on quality assurance, regulatory compliance, and continuous improvement within pharmaceutical/biotech/chemical environments.

The Quality Engineer will lead QA initiatives, manage CAPAs, and support cGMP, ISO standards, and FDA compliance while collaborating with cross-functional teams to uphold quality standards.