Job Description

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

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 1+ years of quality engineering or quality assurance experience in the pharmaceutical, biotech, or medical device industry .
• Strong knowledge of cGMP regulations, FDA/EMA requirements, and quality systems.
• Hands-on experience with CAPA management and deviation investigations.
• Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
• Strong attention to detail, documentation, and organizational skills.
• Excellent communication skills and ability to work collaboratively with cross-functional teams.
• Experience with quality management systems (QMS) or electronic documentation systems preferred.

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