Senior QC Analyst - Environmental Monitoring

Senior QC Analyst – Environmental Monitoring Location: Portsmouth, NH, USA. Schedule: Day Shift, Monday – Friday, 8:00 AM – 5:00 PM. Position Overview As a QC Analyst IV, you are a Subject Matter Expert (SME) and a primary technical lead for the Environmental Monitoring team. This senior role is critical for maintaining the microbial control strategy of our multi-modal facility. You will be responsible for leading complex investigations, driving continuous improvement projects, and ensuring our EM program remains in a permanent state of compliance with global regulatory standards. Key Responsibilities Technical SME Ownership: Serve as the technical lead for the site’s EM and Utility monitoring programs. Provide high‑level guidance on sampling plans, risk assessments, and the qualification of new cleanrooms. Complex Investigations: Lead and author high‑complexity environmental excursion investigations. Utilize root cause analysis (RCA) tools to identify systemic issues and implement effective CAPAs. Data Trending & Strategy: Perform advanced analysis of environmental and utility data. Identify long‑term trends and present findings to site leadership and the Quality Council to drive proactive contamination control. Regulatory & Audit Excellence: Prepare, review, and defend EM data and procedures during regulatory audits. Ensure all department SOPs and sampling protocols meet current Annex 1 and global cGMP expectations. Mentorship & Coaching: Provide advanced technical training and mentorship to LevelI, II, and III analysts. Foster a culture of technical excellence and “Right First Time” performance. Continuous Improvement: Identify and execute Lean Laboratory initiatives to increase efficiency, reduce lead times, and enhance data integrity across the EM program. Review & Approval: Act as a final technical reviewer for complex laboratory records, validation protocols, and summary reports. Qualifications Education: Bachelor’s degree (BS) in a Life Sciences discipline (Microbiology, Biology, or related field) is required. Experience: 5–10 years of advanced experience in Quality Control Microbiology or Environmental Monitoring within a cGMP manufacturing environment. Technical Mastery: Expert‑level knowledge of cleanroom classifications (GradeA–D) and aseptic processing. Deep understanding of global regulatory requirements (FDA, EMA, ICH) for environmental and utility monitoring. Proficiency in utilizing Laboratory Information Management Systems (LIMS) and data trending software. Leadership Attributes: A proven track record of leading projects, managing timelines, and influencing cross‑functional teams without direct authority. Communication: Exceptional technical writing skills and the ability to present complex scientific data clearly to senior management and auditors. Benefits Medical, dental, vision, 401(k), and performance‑based incentives. Comprehensive global benefits. Full list of global benefits: lonza.com/careers/benefits. Equal Employment Opportunity Statement We offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. Ready to lead the standard of excellence in QC? Apply now. #J-18808-Ljbffr