Senior QC Analyst (Environmental Monitoring)

TL;DR

Senior QC Analyst (Environmental Monitoring): Leading the microbial control strategy and Environmental Monitoring program for a multi-modal facility with an accent on regulatory compliance and technical leadership. Focus on leading complex investigations, implementing new technologies, and ensuring adherence to global cGMP standards.

Location: Onsite in Portsmouth, NH, USA

Company

A global leader in biotechnology and pharmaceutical manufacturing with over 30 sites across five continents.

What you will do

• Serve as the technical SME for the site’s EM and Utility monitoring programs, providing guidance on sampling and risk assessments.
• Lead and author high-complexity environmental excursion investigations using root cause analysis (RCA) and CAPA tools.
• Perform advanced analysis of environmental data to identify long-term trends and drive proactive contamination control.
• Represent the EM program as a Subject Matter Expert during regulatory audits by the FDA and EMA.
• Provide technical training and mentorship to Level I, II, and III analysts to foster technical excellence.
• Execute Lean Laboratory initiatives to increase operational efficiency and enhance data integrity.

Requirements

• Bachelor’s degree in Life Sciences (Microbiology, Biology, or related field) is required.
• 5–10 years of advanced experience in QC Microbiology or Environmental Monitoring within a cGMP manufacturing environment.
• Expert-level knowledge of cleanroom classifications (Grade A–D) and aseptic processing.
• Deep understanding of global regulatory requirements (FDA, EMA, ICH).
• Proficiency in utilizing Laboratory Information Management Systems (LIMS) and data trending software.
• Must be located in or able to work onsite in Portsmouth, NH.

Culture & Benefits

• Comprehensive health package including medical, dental, and vision insurance.
• Financial security through a 401(k) plan and performance-based incentives.
• Opportunity to influence site-wide quality culture and operational strategy as a technical lead.
• Work environment based on values of collaboration, accountability, and integrity.