QC Analyst Level IV - Environmental Monitoring

QC Analyst IV – 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.

What You’ll Do

• 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

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, 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. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to lead the standard of excellence in QC? Apply now.