Quality Engineer

Overview

We are seeking a meticulous Quality Engineer to join our team on a contract basis in New Jersey. This entry-level role is tailored for recent graduates who wish to build a career in Quality Assurance, Compliance, and Validation within a regulated pharmaceutical or life sciences environment.

Key Responsibilities

• Assist in the setup and ongoing management of Quality Management Systems (QMS).
• Ensure adherence to Good Manufacturing Practices (GMP) and company-specific standards.
• Support activities involving deviation management, thorough investigations, and root cause analysis.
• Engage in Corrective and Preventive Action (CAPA) processes.
• Examine batch manufacturing records and related quality documentation for accuracy.
• Provide support during internal and external audits, including regulatory and customer inspections.
• Work closely with production, Quality Control (QC), and Research & Development (R&D) teams to ensure quality compliance.
• Assist with process validation efforts and prepare qualification documentation.
• Maintain accurate documentation practices in line with Good Documentation Practices (GDP).
• Monitor and evaluate quality metrics such as deviations and customer complaints to identify trends and areas for improvement.

Required Skills and Knowledge

• Fundamental knowledge of Quality Management Systems (QMS).
• Familiarity with regulatory guidelines such as 21 CFR Part 11 is preferred.
• Understanding of deviation handling, CAPA, and change control processes.
• Analytical mindset with strong problem-solving capabilities.
• Effective documentation and communication skills.
• Proficient in Microsoft Office suite, especially Excel and Word.