Job Description

Quality Applications Engineer- Somerset NJ

Summary of Essential Functions:

The Quality Applications Engineer is tasked with supporting, maintaining, and optimizing digital quality systems and applications across the organization. This role ensures that all quality-related software tools are effectively implemented and aligned with regulatory requirements and business needs. The engineer collaborates with cross-functional teams to drive continuous improvement and system integration.

Specific Duties, Activities, and Responsibilities:

• Serve as the technical lead for quality system applications including QMS, LIMS, and document control platforms.
• Configure, maintain, and troubleshoot quality software tools to ensure optimal performance and compliance.
• Collaborate with IT and Quality teams to implement system upgrades, integrations, and enhancements.
• Develop and maintain user documentation, training materials, and SOPs related to quality applications.
• Support internal and external audits by providing system access, data retrieval, and documentation.
• Analyze system data to identify trends and opportunities for process improvement.
• Ensure systems meet GMP, GLP, and other applicable regulatory standards.
• Provide end-user support and training across departments.
• Participate in validation activities for new systems and upgrades.
• Manage change control processes related to quality applications.
• Comply with Health, Safety, and Environmental responsibilities for the position.
• Adhere to company standards for data integrity and regulatory compliance.

Education and Experience:

• Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
• 3+ years of experience in quality systems or applications support within a regulated industry (pharmaceutical, biotech, or medical device).
• Experience with system validation and compliance documentation (IQ/OQ/PQ).

Knowledge/Skills:

• Strong understanding of GMP/GLP regulations and quality system requirements.
• Hands-on experience with QMS platforms: MasterControl, Veeva Vault, LIMS and ERP required
• Familiarity with FDA 21 CFR Part 11 compliance and data integrity principles.
• Proficiency in SQL, data visualization tools, and reporting platforms.

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