In Process Quality Assurance Associate

Position Summary

The In-Process Quality Assurance Associate is responsible for real-time oversight of manufacturing operations within the cell and gene therapy facility. This individual will be present on the production floor, observing and verifying compliance with Good Manufacturing Practices (GMP) and company procedures, ensuring that any deviations are immediately addressed.

Key Responsibilities:

• Provide on-the-floor presence during all stages of manufacturing to ensure adherence to GMP, standard operating procedures (SOPs), and quality standards.
• Monitor critical production processes in real-time to identify any issues, deviations, or non-conformances and report them promptly to relevant departments.
• Review and verify batch records, logbooks, and other documentation for completeness and accuracy during and after production runs.
• Act as a quality resource for manufacturing staff, ensuring proper training and understanding of quality processes.
• Conduct in-process quality checks, including environmental monitoring, sample collection, and visual inspections of product and equipment.
• Support investigations of deviations, non-conformances, and CAPAs, ensuring that corrective actions are implemented in a timely manner.
• Collaborate with cross-functional teams, including manufacturing, engineering, and maintenance, to resolve any on-the-floor quality issues as they arise.
• Participate in daily production meetings to provide real-time quality feedback and contribute to continuous improvement initiatives.
• Ensure compliance with FDA, EMA, and other regulatory requirements specific to cell and gene therapy manufacturing.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, Biotechnology, or a related field preferred.
• 3+ years of experience in Quality Assurance or a related role in pharmaceutical or biotechnology manufacturing, with cell and gene therapy experience being a plus.
• Solid understanding of GMP regulations and quality systems, particularly in a hands-on manufacturing environment.
• Strong attention to detail with the ability to identify quality issues during production.
• Excellent communication skills and the ability to work closely with cross-functional teams.
• Ability to work in a fast-paced, regulated environment and make quick, informed decisions.
• Familiarity with batch record review, in-process quality control, and environmental monitoring.

Preferred Qualifications:

• Experience in a cell and gene therapy manufacturing environment.
• Knowledge of electronic batch record systems and other quality documentation tools.
• Familiarity with FDA and EMA regulations specific to advanced therapies.

*Multiple shifts available*

If you are a dedicated professional with a passion for quality and excellence, we encourage you to apply through the link provided.