QC Analyst Level IV - Environmental Monitoring

Lonza•Portsmouth, NH

15h•Onsite

About The Position

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.

Requirements

Bachelor’s degree (BS) in a Life Sciences discipline (Microbiology, Biology, or related field) is required.
5–10 years of advanced experience in Quality Control Microbiology or Environmental Monitoring within a cGMP manufacturing environment is required.
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.
A proven track record of leading projects, managing timelines, and influencing cross-functional teams without direct authority.
Exceptional technical writing skills and the ability to present complex scientific data clearly to senior management and auditors.

Responsibilities

Act as a lead for the EM department, influencing site-wide quality culture and operational strategy.
Represent the EM program as a Subject Matter Expert during internal and external regulatory inspections (FDA, EMA, etc.).
Lead the implementation of new technologies, such as rapid microbiological methods or paperless data systems.
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.
Lead and author high-complexity environmental excursion investigations. Utilize root cause analysis (RCA) tools to identify systemic issues and implement effective CAPAs.
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.
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.
Provide advanced technical training and mentorship to Level I, II, and III analysts. Foster a culture of technical excellence and "Right First Time" performance.
Identify and execute Lean Laboratory initiatives to increase efficiency, reduce lead times, and enhance data integrity across the EM program.
Act as a final technical reviewer for complex laboratory records, validation protocols, and summary reports.