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Quality Manufacturing Engineer

Phillipsburg, NJ, US • Posted 3 hours ago • Updated 3 hours ago

Contract W2

On-site

Depends on Experience

Fitment

Dice Job Match Score™

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Job Details

Skills

Biotechnology
ISO 9000
ROOT
Regulatory Compliance
Good Manufacturing Practice
Pharmaceutics
Manufacturing
Corrective And Preventive Action

Summary

Title- Quality Engineer Location:  Phillipsburg, NJ - Onsite    Job Summary   We are seeking a Quality Engineer with 5+ years of experience in regulated manufacturing environments. The ideal candidate will support quality assurance programs, ensure compliance with cGMP, ISO, and FDA requirements, and drive continuous improvement initiatives across quality systems and processes.   Key Responsibilities

Support and maintain quality systems including CAPA, Complaint Handling, Validation, Stability, and SPC.

Conduct root cause investigations and implement corrective and preventive actions.

Ensure compliance with cGMP, ISO 9000, FDA, ICHQ7, and IPEC requirements.

Participate in internal, customer, and regulatory audits.

Investigate customer complaints and coordinate resolution activities.

Analyze quality data and support process improvement initiatives.

Collaborate with cross-functional teams to enhance product and process quality.

Required Qualifications

5+ years of Quality Engineering or Quality Assurance experience.

Experience in Pharmaceutical, Biotechnology, Chemical, or related regulated industries.

Strong knowledge of cGMP, ISO 9000, FDA regulations, CAPA, Validation, and Audit processes.

Experience with complaint investigations, root cause analysis, and quality system management.

Strong communication and problem-solving skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10439527
Position Id: 9067794
Posted 3 hours ago

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Pooja Sahoo

Recruiter @ Tranzeal, Inc.

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