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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
The Analyst II, QC Micro – Aseptic, Lead
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.
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 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
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 (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 origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.
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.
RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.
Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience.
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Worksite address
north olmsted, OH, 44070, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.