Work Location: Warren County, New Jersey

Summary:

The Quality Engineer is responsible for leading quality assurance initiatives, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems. This role involves direct interaction with customers, management of audits, and collaboration across multiple departments to resolve quality issues and enhance operational performance.

Responsibilities:

• Lead quality management system improvement activities to maintain compliance with ISO, GMP, and regulatory requirements.
• Investigate and resolve customer complaints, collaborating with both customers and suppliers to ensure satisfaction and compliance.
• Manage and execute audit activities, including internal, customer, and regulatory audits, and implement corrective actions for identified gaps.
• Oversee Corrective and Preventive Action (CAPA) program activities, ensuring effective resolution of quality issues.
• Provide training on GMP and GDP to site personnel and support ongoing compliance initiatives.
• Conduct statistical evaluations and lead validation activities for new products or process changes.
• Collaborate with supplier quality teams and internal departments to address and resolve quality-related challenges.
• Drive improvements in global quality metrics, focusing on complaint response times and CAPA effectiveness.

Qualifications:

• Bachelor’s degree in chemistry or a related field required.
• Minimum of five (5) years of experience in quality engineering or a related role required.
• Experience in pharmaceutical, biotechnology, and/or chemical environments required.
• Experience working within cGMP/ISO 9000 regulated environments required.
• Excellent writing, presentation, and organizational skills.
• Strong analytical, problem-solving, and project management abilities.
• Ability to work collaboratively in a matrixed environment and interface with all organizational levels.
• Familiarity with chemical nomenclature and quality control testing methods.
• Demonstrated ability to lead cross-functional teams and accomplish goals through others.
• Detail-oriented with strong communication and interpersonal skills.
• Occasional domestic travel required; must be able to work in a manufacturing facility with appropriate PPE.

Published Category: Quality & Validation