Analyst II, QC Micro - Aseptic, Lead

resilience; Olde West Chester (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Resilience is a technology-focused biomanufacturing company changing how medicine is made. We’re building a sustainable network of high-tech manufacturing solutions to withstand disruptions, support scientific discovery, and reach those in need.

This role focuses on Environmental Monitoring execution, data review, scheduling, and team support within a 24/7 operation. The candidate will analyze EM data, lead investigations, train team members, and coordinate daily activities with cGMP compliance.

Qualifications

• 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
• 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 and abnormalities; review production documentation and logbooks for quality, completeness, 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; serve as the primary link between QC and Operations for scheduling and workload planning.
• Training & Team Support: Train team members on systems, software, equipment, procedures, and processes; communicate policies and priorities; ensure the team has tools and training; fill in for immediate supervisor; perform other duties supporting EM, Operations, or Laboratory processes
• Experience to coordinate daily activities of a team of technicians and provide technical direction on EM operations

Skills

EM data analysis

Team leadership

Training others

Coordination & scheduling

Education

Bachelor's degree in a scientific discipline

Tools

MODA

Novatek

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Job Responsibilities

Environmental Monitoring Execution & Data Review

• 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

Scheduling & Workflow Coordination

• 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

Training & Team Support

• 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 & Education

Minimum Qualifications

• 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 scopeAbility 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

Preferred Qualifications

• 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

Physical & Work Environment

This is primarily a non-sedentary role.

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 ( Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors; seeing with 20/20 (or better) vision, with or without correction.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Work Schedule:

Day Shift: 12 hour - 2/2/3 work schedule.

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national