Analyst II, QC Micro – Aseptic, Lead

About the role

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.

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 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

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

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.

Pay

Our target base pay hiring range for this position is $60,000.00 - $86,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge.

Benefits

• Annual cash bonus program
• 401(k) plan with a generous company match
• Healthcare (including medical, dental and vision)
• Family building benefits
• Life and disability insurance
• Paid vacation
• Paid holidays
• Other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs