QA Specialist I ACM

JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge tothousands of biopharma companies and their patients. We are PCI. Ourinvestment is in People who make an impact, drive progress and create abetter tomorrow. Our strategy includes building teams across our globalnetwork to pioneer and shape the future of PCI. The Quality SpecialistI - Aseptic Core Monitor (ACM) at PCI Pharma Services is a criticalmember of the aseptic operations team responsible for ensuring that allactivities 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 sterilemanufacturing, including gowning, interventions, environmentalmonitoring, and material handling in ISO 5/ISO 6 environments. This rolesupports PCI's mission of maintaining a high standard of asepticintegrity, product quality, and patient safety. ESSENTIAL DUTIES ANDRESPONSIBILITIES: Provide continuous oversight of operator performanceand aseptic behavior inside the ISO 5 core and adjacent classifiedareas. Observe and document real-time activities during manufacturingoperations, including setup, filling, environmental monitoring,sanitization and routine/corrective interventions. Ensure compliancewith PCI aseptic technique expectations, gowning standards, andcleanroom behavior as outlined in SOPs and training. Identify andescalate deviations from aseptic practices, personnel behaviors, orenvironmental controls that pose potential contamination risks. Capturedetailed and objective records of events, interventions, andnonconformances using PCI-approved documentation tools or checklists.Support media fill (aseptic process simulation) operations by providingvisual monitoring and feedback throughout the process. Collaborate withQuality Assurance, Operations, Microbiology, and Training to identifyopportunities for coaching, retraining, and continuous improvement.Participate in contamination control and environmental monitoringtrending to drive site-level improvements and reduce contamination risk.Assist with investigations and root cause analysis for contaminationevents, EM excursions, and aseptic technique deviations. QUALIFICATIONS:Required: High School Diploma or GED required, Associate's orBachelor's degree in Life Sciences / related field or experience inleadership role preferred. Minimum 1-2 years' experience in sterile...For full info follow application link. LSNE is an EEO/AA Employer andall qualified applicants will receive consideration for employmentwithout regard to, their race, color, religion, sex, age, nationalorigin, ancestry, sexual orientation, gender identity, disability,protected genetic information, protected veteran status, militaryservice, or other protected status. The Company's EEO policy, as wellas its affirmative action obligations, include the full and completesupport of The Company. APPLICATION INSTRUCTIONS: ApplyOnline: ipc.us/t/012A77B207F5475C

Created: 2026-03-30