Overview:

We are seeking a highly skilled Biologics Manufacturing Investigator to join our dynamic team. As a key member of our manufacturing operations, you will be responsible for investigating deviations, conducting root cause analysis, and implementing corrective and preventive actions (CAPAs) within our biologics manufacturing facility. Your expertise will ensure compliance with regulatory requirements and contribute to the continuous improvement of our manufacturing processes.

Key Responsibilities:

• Conduct thorough investigations of deviations and anomalies identified during biologics manufacturing processes.
• Initiate quality records in the Veeva Quality Management System (QMS).
• Collaborate with cross-functional teams including Quality Assurance, Quality Control, Engineering, and Manufacturing to determine corrective and preventive actions.
• Document investigation findings, root cause analysis, and CAPAs in compliance with regulatory guidelines and internal procedures.
• Evaluate manufacturing processes and recommend improvements to enhance efficiency, quality, and compliance.
• Experience in cell culture or aseptic processing
• Experience in cGMP cell therapy manufacturing
• Technical Writing Experience

Qualifications:

• Bachelor’s degree/ AA in Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field.
• Proven experience (3 years) in biologics manufacturing, with a strong understanding of GMP (Good Manufacturing Practices) and regulatory requirements (FDA, EMA, etc.).
• Demonstrated experience in conducting investigations and root cause analysis within a biologics manufacturing environment.
• Experience with quality systems (e.g., Veeva, TrackWise, Quality Management Systems) and investigation tools.