Analyst II, QC Micro – Aseptic, Lead

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The Analyst II, QC Micro – Aseptic, Lead performs and coordinates environmental monitoring operations in classified and non-classified areas up to Grade A at a sterile pharmaceutical manufacturing site. Working with limited supervision, the role self-directs EM scheduling and sampling workload, reviews data and documentation for trends and cGMP compliance, and leads investigations and process improvement activities within its scope. The role serves as the day-to-day operational link between QC Microbiology and Operations and supports the qualification and technical development of EM technicians.

• Maintain qualification to perform all EM technician responsibilities, including aseptic gowning
• Verify QC data and monitor for trends and abnormalities
• Review production documentation and logbooks for quality, completeness, and cGMP compliance
• Troubleshoot and develop EM methods and processes
• Lead and coordinate investigations and process improvement activities with limited supervision

• Schedule work and load pulls in the Environmental Monitoring System
• Coordinate workflow and assign tasks and activities within the Environmental Monitoring team
• Serve as the primary link between QC and Operations for scheduling and workload planning

• Train team members on systems, software, equipment, procedures, and processes
• Communicate policies, procedures, and operational priorities to the team
• Ensure the team has the tools and training needed to perform their work in compliance
• Fill in for the immediate supervisor as needed
• Perform other duties supporting Environmental Monitoring, Operations, or Laboratory processes

• Experience as a skilled specialist in sterile pharmaceutical production or QC, with the ability to self-direct work across short- and long-term priorities
• Ability to independently analyze EM data, identify trends and root causes, and decide on corrective actions within scope
• Ability to lead investigations and complete complex tasks with limited supervision, applying specialist knowledge of aseptic operations and cGMP requirements
• Experience training and providing technical guidance to others
• Demonstrated ability to coordinate the daily activities of a team of technicians and provide technical direction on EM operations

• Bachelor’s degree in a scientific discipline
• 2+ years of experience in a pharmaceutical quality control or sterile manufacturing environment
• Working knowledge of MODA, Novatek, or equivalent EM software
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc. Occasional (20–60% of time): sitting, walking, and monitoring other people's work. Infrequent (