QA Specialist I - ACM

The Quality Specialist I - ACM provides real-time monitoring 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.

Responsibilities

Review operator’s aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor; Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions; Ensure compliance with PCI aseptic technique expectations, gowning standards, and cleanroom behavior as outlined in SOPs and training; Identify and escalate deviations from aseptic practices, personnel behaviors, or environmental controls that pose potential contamination risks; Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists; Support media fill (aseptic process simulation) operations by providing visual monitoring and feedback throughout the process; Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify opportunities for coaching, retraining, and continuous improvement; Participate in contamination control and environmental monitoring trending to drive site-level improvements and reduce contamination risk; Assist with investigations and root cause analysis for contamination events, EM excursions, and aseptic technique deviations

Requirements

High school Diploma, GED, or equivalent credential required; 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP-regulated environment; equivalent combination of education and experience will be considered; Ability to learn aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1); Demonstrated ability to observe critically and document behaviors accurately and objectively; Excellent verbal and written communication skills; must be comfortable providing real-time coaching; Ability to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods

Nice to have

AS degree or BS degree in Life Sciences or related field; Proficient in Microsoft Office and electronic quality systems; Prior experience in a QA or manufacturing oversight role at PCI or a similar aseptic operation