Quality Assurance Specialist

We are seeking a highly motivated Quality Assurance Specialist II to join our team and help ensure compliance with quality objectives and regulatory requirements in a fast-paced biopharma environment. Key Responsibilities Perform QA-related production activities, including batch record review, line clearance, and on-the-floor support Provide QA oversight for QC activities ( method transfer, Certificate of Analysis, stability ) Approve shipments and oversee product packaging Ensure timely closure of deviations, CAPAs, change controls, laboratory investigations, and batch/material holds Conduct walk-throughs and process observations to ensure GMP compliance Support regulatory inspections and maintain document control/training records Escalate compliance risks and issues affecting product release Generate and update procedures and forms as needed Preferred Qualifications Background in analytical, virological, or microbiological QC Strong knowledge of U.S. and EU GMP standards Experience with Veeva, Smartsheet, and LIMS preferred Excellent interpersonal, verbal, and written communication skills Comfortable working in a fast-paced, dynamic environment Education Requirements Master’s Degree OR Bachelor’s Degree + 2+ years of experience in biological sciences OR AA Degree + 4+ years’ experience OR High School Diploma + 5+ years’ experience If you have a hands-on QA background in a GMP manufacturing environment and thrive in a collaborative, high-compliance setting, we’d love to hear from you! #J-18808-Ljbffr