Associate-Quality Assurance-1

Responsibilities

• Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change control activities to ensure compliance with USDA, FDA, and EU regulations.
• Provide real-time, on-the-floor quality support for batch reviews, process auditing, and quality guidance to production personnel and the Process Team.
• Support the deviation management process by identifying non-conformances, determining root cause, and participating in investigation report writing.
• Aid in internal and external inspection audits by helping with preparation and response, and support the Process Team by tracking and reporting on continuous improvement goals.
• Execute usage decisions and release transactions in SAP to manage product movement and final disposition for product release.

Qualifications

• Education: Bachelor's Degree in a scientific discipline; or a High School Diploma / GED with equivalent relevant experience.
• Experience: At least 1-2 years of experience in a GMP-regulated environment, such as pharmaceuticals or biologics.
• Documentation Skills: Demonstrated experience reviewing GMP-regulated documents such as batch records, Standard Operating Procedures (SOPs), and quality investigations.
• Systems Proficiency: Strong attention to detail; proficiency with computer systems including Microsoft Suite, SAP, and Veeva.