Senior QC Analyst - Environmental Monitoring

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 Level I, 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.
• Who We're Looking For
• 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 is required .
• Technical Mastery: * Expert-level knowledge of cleanroom classifications (Grade A-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.
• About Lonza
• Ready to lead the standard of excellence in QC?

Benefits

Additional Information

Senior QC Analyst - Environmental Monitoring Location: Portsmouth, NH, USA. 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. Schedule: Day Shift, Monday - Friday, 8:00 AM - 5:00 PM What You'll Get Technical Leadership: Act as a lead for the EM department, influencing site-wide quality culture and operational strategy. Audit Frontline: Represent the EM program as a Subject Matter Expert during internal and external regulatory inspections (FDA, EMA, etc.). Advanced Project Ownership: Lead the implementation of new technologies, such as rapid microbiological methods or paperless data systems. Comprehensive Benefits: Medical, dental, vision, 401(k), and performance-based incentives. Our full list of global benefits: lonza.com/careers/benefits .

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