Quality Engineer (Contract) – GMP / ISO Environment

Quality Engineer (Contract) – GMP / ISO Environment

Location: Phillipsburg, NJ (100% Onsite)

Schedule: Monday–Friday, 8:00 AM – 5:00 PM (flexible)

Duration: Up to 18 months (contract)

Compensation: $36–$43/hour (based on experience)

Start Date: ASAP

Overview

Our client, a leading organization in regulated manufacturing, is seeking a Quality Engineer to support site-level quality assurance programs and continuous improvement initiatives. This individual will play a critical role in ensuring compliance with cGMP, ISO standards, and regulatory requirements, while partnering cross-functionally to drive quality performance and operational excellence.

Key Responsibilities

• Lead and support Quality Management System (QMS) initiatives to ensure compliance with GMP and ISO requirements
• Drive customer complaint investigations, working directly with customers and suppliers to resolve issues
• Manage and participate in internal, customer, and regulatory audits, including gap assessments and corrective actions
• Own and maintain CAPA (Corrective and Preventive Action) processes within assigned scope
• Ensure ongoing cGMP compliance and identify opportunities for process and system improvements
• Deliver GMP/GDP training to site personnel
• Monitor and improve quality metrics, including complaint response times and CAPA effectiveness
• Support Change Control (Management of Change) processes
• Conduct statistical analysis and process trending (SPC) to support data-driven decisions
• Lead or support validation activities for new and existing products/processes
• Collaborate with supplier quality teams to resolve material and performance issues
• Partner with operations, R&D, procurement, and commercial teams to address quality concerns
• Support cross-functional investigations into product and process deviations

Qualifications

• Bachelor’s degree in Chemistry or related scientific field
• 5 years of experience in quality engineering or related role
• Experience in pharmaceutical, biotechnology, or chemical manufacturing environments
• Strong knowledge of cGMP and ISO 9000 standards
• Minimum 3 years in a GMP-regulated manufacturing facility

Key Skills & Competencies

• Strong analytical and problem-solving abilities
• Excellent written and verbal communication skills
• Experience with quality systems: CAPA, audits, validation, complaint handling
• Familiarity with chemical nomenclature and QC testing methods
• Ability to work effectively in a matrixed, cross-functional environment
• Strong project management and organizational skills
• Proven ability to influence and lead without direct authority

Work Environment

• Manufacturing setting requiring appropriate PPE in designated areas
• Occasional domestic travel may be required

Interview Process

• Initial 15-minute virtual interview
• Final onsite interview (approximately 2 hours) with cross-functional team