QA Specialist I - ACM

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Quality Specialist I - Aseptic Core Monitor (ACM) at PCI Pharma Services is a critical member of the aseptic operations team responsible for ensuring that all activities within the aseptic core align with regulatory expectations, PCI procedures, and industry best practices. The Quality Specialist I - ACM provides real-time oversight of aseptic behaviors during sterile manufacturing, including gowning, interventions, environmental monitoring, and material handling in ISO 5/ISO 6 environments. This role supports PCI’s mission of maintaining a high standard of aseptic integrity, product quality, and patient safety. QUALIFICATIONS: Required: Preferred: - Provide continuous oversight of operator performance and aseptic behavior inside the ISO 5 core and adjacent classified areas. - Observe and document real-time activities during manufacturing operations, including setup, filli...