QA Engineer**30​/HR

QA Engineer

The QA Engineer develops, maintains, and continuously improves quality management systems and processes to ensure full compliance with FDA regulations and current GMP requirements. This role focuses on quality systems in a GMP manufacturing environment, supporting both manufacturing and distribution operations, driving investigations and CAPAs, and contributing to process optimization and continuous improvement while managing projects and timelines effectively.

Responsibilities:

• Develop, monitor, and improve quality management systems and processes to ensure compliance with FDA regulations and current GMP requirements.
• Ensure GMP-required documentation adheres to applicable governmental regulations related to food, drug, and cosmetic industries.
• Monitor and interpret the Federal Register and other regulatory sources to stay current on laws and guidance affecting quality and compliance.
• Define and improve systems and processes to strengthen the overall quality system and operational efficiency.
• Maintain the quality system for Process Variance Reports (PVR) across manufacturing and distribution locations.
• Generate and maintain Annual Product Reviews (APR) for relevant products and facilities.
• Conduct and support customer complaint investigations, ensuring timely, thorough, and well-documented outcomes.
• Maintain and update quality attributes within customer specification portals to ensure accurate and compliant product information.
• Develop or assist with process control procedures and automation specifications to support ongoing compliance and robust process control.
• Evaluate data from current processes to recommend improvements that enhance cost effectiveness and production quality.
• Investigate root causes of quality issues, write and implement CAPAs, and collaborate with cross-functional departments to ensure effective resolution.
• Respond promptly to quality events and deliver high-quality investigations and comprehensive CAPA documentation.
• Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) studies to assess systems and processes and identify potential risks.
• Assist in GMP and GDP training for new personnel, reinforcing quality and documentation best practices.
• Create or modify standard operating procedures (SOPs) and work instructions, and recommend changes to batching instructions as needed.
• Perform statistical process analysis to evaluate process control and identify opportunities for improvement.
• Coordinate resources and communicate project progress using project management tools and techniques for multiple concurrent projects.
• Participate in or support internal and external audits of manufacturing areas, including FDA and customer audits, and contribute to deviation and complaint investigations.
• Exhibit strong team player qualities by cooperating and coordinating with colleagues and maintaining professional interaction in all business contacts.

Essential

Skills:

• Bachelor's degree in a related science or engineering field.
• A minimum of 1–3 years of quality experience in a GMP manufacturing environment (such as food, consumer products, cosmetics, or pharmaceuticals) strongly preferred.
• Hands-on experience with quality systems, including CAPA, deviations, auditing, and complaint management.
• Solid knowledge of current GMPs and FDA regulations and the ability to develop technically compliant documents.
• Experience participating in FDA or customer audits with an understanding of audit expectations and requirements.
• Broad quality assurance experience in quality systems, with the ability to manage projects and drive processes forward.
• Demonstrated ability to function effectively both as an individual contributor and as a collaborative team member.
• Strong project management skills, including the ability to coordinate resources and communicate progress across multiple projects.
• Comfort with escalating issues when necessary to ensure timely resolution and compliance.
• Proficiency in Microsoft Office products for documentation, analysis, and communication.
• Ability to perform statistical process analysis and interpret data to support process control and improvement.
• Strong investigative mindset…