Overview
Quality Engineer Jobs in Warren County, NJ at Astrix
Title: Quality Engineer
Company: Astrix
Location: Warren County, NJ
Our client, a Fortune 500 industry leader, is seeking a skilled Quality Engineer to join their growing team. This is an exciting opportunity to contribute to cutting-edge advancements across the biopharma, healthcare, and advanced technology sectors while supporting critical quality and compliance initiatives in a GMP-regulated manufacturing environment.
Position Details
- Project Duration: Up to 18 months (Temporary Assignment)
- Schedule: Monday–Friday, 8:00 AM–5:00 PM EST (flexible 8-hour workday)
- Overtime: Available with prior approval
- Work Arrangement: 100% Onsite
Please note: At this time, we are only considering local candidates who are able to work onsite as required. Unfortunately, we are unable to provide visa sponsorship or accommodate Corp-to-Corp (C2C) arrangements for this opportunity.
Required Qualifications
- Bachelor’s degree in Chemistry or related scientific discipline
- Minimum 3 years of experience in a GMP manufacturing environment
- 3–5 years of Quality Assurance experience within a regulated industry
Position Overview
The Quality Engineer is responsible for leading quality assurance initiatives and continuous improvement activities to support site-wide compliance with cGMP regulations, ICH Q7, IPEC guidelines, ISO standards, and FDA requirements. This role provides direct support for key quality systems including CAPA, complaint investigations, validation, stability, SPC, and ISO quality systems across pharmaceutical, reagent, and microelectronic product lines.
This individual will serve as a primary point of contact for customer quality concerns, audits, and investigations while partnering cross-functionally with operations, R&D, procurement, commercial teams, and external suppliers to drive quality excellence and regulatory compliance.
Key Responsibilities
- Lead quality system improvement initiatives to ensure compliance with GMP and ISO requirements
- Manage and support customer complaint investigations, including direct communication with customers and suppliers
- Coordinate and lead internal, customer, GMP, regulatory, and certification audits
- Identify compliance gaps and implement effective corrective actions
- Support and maintain CAPA activities and continuous improvement efforts
- Ensure ongoing facility compliance with cGMP standards
- Deliver GMP and GDP training to site personnel
- Monitor and improve quality metrics related to complaints, CAPAs, and response timelines
- Participate in Management of Change activities
- Perform statistical analysis, process trending, and validation activities for new and existing products/processes
- Collaborate with supplier quality teams to resolve quality-related issues
- Investigate and resolve process and product quality concerns across departments
- Support additional quality initiatives and responsibilities as assigned
Preferred Skills & Experience
- Strong knowledge of GMP, GDP, FDA, ISO, and quality systems
- Experience with CAPA management, validation, and audit leadership
- Excellent problem-solving, communication, and cross-functional collaboration skills
- Ability to work effectively in a fast-paced manufacturing environment
- Strong organizational and analytical abilities
**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**
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