Lead QC Micro Analyst, Aseptic Operations

Resilience; Olde West Chester (OH); On-site; USD 60,000 - 86,000; Full time

Job summary

Resilience seeks an Analyst II, QC Micro – Aseptic, Lead to oversee environmental monitoring operations in sterile pharmaceutical manufacturing. You will self-direct EM scheduling, review data for trends, and lead investigations within cGMP scope, acting as liaison between QC Microbiology and Operations.

The role requires coordinating EM workloads, training teammates, and ensuring compliance with SOPs. Day-to-day activities demand attention to detail and strong teamwork in a highly regulated

Qualifications

• Experience as a skilled specialist in sterile pharmaceutical production or QC and 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.

Responsibilities

• Environmental Monitoring Execution & Data Review: Maintain qualification to perform all EM technician responsibilities, including aseptic gowning; verify QC data and monitor for trends, abnormalities; review production documentation for quality and cGMP compliance; troubleshoot and develop EM methods and processes; lead investigations and process improvements with limited supervision.
• Scheduling & Workflow Coordination: Schedule work and load pulls in the Environmental Monitoring System; coordinate workflow and assign tasks within the EM team; act as primary link between QC and Operations for scheduling.
• Training & Team Support: Train team members on systems, software, equipment, procedures, and processes; communicate policies and priorities; ensure tools and training; fill in for supervisor as needed; support other related processes.

Skills

Self-direction

Data analysis

Investigations leadership

Training others

Team coordination

cGMP knowledge

Education

Bachelor’s degree in a scientific discipline

Tools

MODA

Novatek

Job description

Resilience seeks an Analyst II, QC Micro – Aseptic, Lead to oversee environmental monitoring operations in sterile pharmaceutical manufacturing. You will self-direct EM scheduling, review data for trends, and lead investigations within cGMP scope, acting as liaison between QC Microbiology and Operations.

The role requires coordinating EM workloads, training teammates, and ensuring compliance with SOPs. Day-to-day activities demand attention to detail and strong teamwork in a highly regulated