QA Specialist I ACM

JOB REQUIREMENTS: 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. Position Title: Quality Specialist I - ACM Location: Madison, Wisconsin Department: Quality Assurance Reporting To: Supervisor, Quality Assurance Internal Operations Responsible For (Staff): No 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. ESSENTIAL DUTIES AND 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. QUALIFICATIONS: Required: High school Diploma, GED, or equivalent credential required, AS degree or BS degree in Life Sciences or related field preferred. 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a... For full info follow application link. LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/BAC6F18D687D40EE