Analyst II, QC Micro - Aseptic, Lead

Resilience; Port Union (OH); On-site; USD 60,000 - 86,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare (medical, dental, vision)

Tuition reimbursement

Paid vacation and holidays

Job summary

Resilience is a technology-focused biomanufacturing company actively building a high-tech network of manufacturing solutions. The Analyst II, QC Micro - Aseptic role focuses on environmental monitoring execution, data review, and investigations at a sterile pharmaceutical site.

The position involves coordinating EM workload, training team members, and ensuring cGMP compliance, with on-site work and potential on-call requirements. A bachelor’s degree in science is preferred.

Qualifications

• Experience as a skilled specialist in sterile pharmaceutical production or QC.
• Ability to independently analyze EM data and identify trends.
• Ability to lead investigations and complete complex tasks with limited supervision.
• Experience training and guiding others in EM operations.
• Ability to coordinate daily activities of a team of technicians.

Responsibilities

• Maintain qualification to perform all EM technician responsibilities including aseptic gowning.
• Verify QC data and monitor for trends and abnormalities.
• Review production documentation for quality and cGMP compliance.
• Lead investigations and process-improvement activities with limited supervision.
• Schedule work and load pulls in the Environmental Monitoring System.

Skills

EM data analysis

Lead investigations

Team coordination

Self-direction

Training others

Education

Bachelor's degree in science

Tools

MODA

Novatek

EM software

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

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

• 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 (<20% of time): lifting/carrying up to 30 lbs., working at heights of 5 ft., bending, stooping, twisting, reaching, noise exposure, operating moving machinery, chemical usage with potential exposure to area chemicals requiring handling precautions per SOP, traveling, and speaking publicly.
• 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 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.