Quality Engineer

Job Description

Position Overview

We are seeking a detail-oriented and proactive Quality Engineer to join our pharmaceutical manufacturing team. This role will play a critical part in ensuring compliance with cGMP standards by leading investigations, managing Corrective and Preventive Actions (CAPAs), and overseeing deviation reporting. The Quality Engineer will collaborate with cross-functional teams to identify root causes, drive effective corrective actions, and continuously improve product quality and manufacturing processes.

This is a contract position through the end of the year with a VERY high likelihood of extension.

Key Responsibilities

• Lead and support investigations of product and process deviations, ensuring timely and thorough documentation.
• Manage the full lifecycle of CAPAs, including initiation, root cause analysis, action plan development, implementation, and effectiveness checks.
• Ensure all deviation and CAPA records are compliant with regulatory requirements, internal SOPs, and cGMP standards.
• Collaborate with production, engineering, validation, and QC teams to develop robust solutions to quality issues.
• Prepare and present investigation findings, trend reports, and CAPA effectiveness data to quality management.
• Support audits and regulatory inspections by providing documentation and explanations of CAPA and deviation processes.
• Identify opportunities for process improvements and provide recommendations to enhance product quality and compliance.
• Train employees on deviation reporting, investigation processes, and CAPA management as needed.

Qualifications