Quality Technician II, QC Aseptic

Resilience; Northern (KY); Hybrid; USD 61,992,000 - 88,166,000; Full time

Job summary

Resilience is seeking a Quality Technician II, QC Aseptic Control Micro, to support aseptic manufacturing at the WCH site. You will perform environmental monitoring and microbial sampling, maintain cGMP documentation, and ensure procedures meet SOPs.

The ideal candidate has 1+ year in pharma/biotech, familiarity with MODA, LIMS or Novatek, and lean manufacturing exposure. Schedule: 6am–6:30pm on a 12‑hour 2/2/3 cycle; on‑call duties may apply; visa sponsorship is not available.

Qualifications

• Follow SOPs and work instructions with minimal supervision.
• Strong attention to detail and accurate recordkeeping.
• Read, write and follow English instructions.

Responsibilities

• Document activities and results per SOPs; maintain records.
• Perform visual inspections and sampling using EM System for data entry.
• Follow cGMP requirements and SOPs; report deviations.
• Maintain clean, compliant work area and equipment; support training.

Skills

Environmental monitoring

Microbial sampling

cGMP documentation

SOP adherence

English proficiency

Education

High school diploma

Vocational training

Tools

MODA

LIMS

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

The Quality Technician II, QC Aseptic Control Micro – Aseptic Control Technician performs environmental monitoring and microbial sampling activities in classified and non-classified areas, including Class 100/ISO 5 aseptic environments, in support of sterile manufacturing operations at the WCH site. Working under established procedures and SOPs, this role collects and analyzes environmental samples, maintains accurate cGMP documentation, and ensures laboratory activities are conducted in a state of compliance.

Job Responsibilities

• Document activities, actions, and results per documentation practices; read SOPs and technical documentation as required, and maintain accurate, complete records (e.g., laboratory notebooks, quality records, sample receipts).
• Perform visual inspections and routine sampling activities, including using the Environmental Monitoring System to collect and analyze samples, with associated data entry.
• Follow SOPs, control documents, and work instructions; perform laboratory duties consistent with cGMP requirements.
• Maintain work area and equipment in a state of compliance with applicable SOPs and cGMP requirements; report deviations or non-conformances to supervisor.
• Audit SOPs and work instructions; recommend and initiate activities to keep area and equipment in a state of compliance.
• Support the training of new technicians

Experience & Education Minimum Qualifications

• Ability to follow written procedures, SOPs and work instructions with minimal supervision, escalating issues as needed.
• Strong attention to detail, with the ability to keep accurate records and perform mathematical calculations.
• Ability to effectively read, write, speak, and follow instructions English.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Working knowledge of Microsoft applications, MODA, LIMS, Novatek, or equivalent sampling and testing 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 that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP. Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc. Using a computer keyboard, mouse, or other electronic/laboratory device; 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.

Work Schedule

Work Schedule: 6am - 630pm working a 12-hour 2/2/3 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.

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.

Equal Employment Opportunity

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 $21.50 - $30.50 per hour. 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.