Quality Technician II, Aseptic Control (Day Shift - 12-Hour Rotating Schedule)

Resilience US, LLC; Olde West Chester (OH); On-site; USD 30,000 - 42,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Comprehensive healthcare

Paid vacation and holidays

Job summary

Resilience, Inc. is seeking a Quality Technician II, QC Micro – Aseptic Control at our WCH site. You will perform environmental monitoring and microbial sampling in classified and non-classified areas, supporting sterile manufacturing operations under cGMP.

The role requires following SOPs, maintaining accurate records, and helping train new technicians. Schedule is day shift with 12-hour shifts; sponsorship is not available.

Qualifications

• Ability to follow written procedures and SOPs with minimal supervision.
• Strong attention to detail and accurate record keeping.
• Effective reading, writing, speaking and instruction following in English.
• High school diploma or equivalent; 1+ years in pharma/biotech cGMP env.
• Experience with sampling software MODA, LIMS, Novatek.

Responsibilities

• Document activities and results per SOPs and maintain records.
• Perform visual inspections and routine sampling using EM system.
• Follow SOPs and cGMP requirements in daily work.
• Maintain area and equipment compliance; report deviations.
• Audit SOPs; initiate activities to ensure compliance.
• Support training of new technicians.

Skills

Attention to detail

Documentation

English proficiency

Math skills

SOP compliance

GxP knowledge

Education

High school diploma or equivalent

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 is changing the way medicine is made. We are 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 Micro – Aseptic Control 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.

Core 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.

Minimum Qualifications (Experience & Education)

• 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

Day shift: 6AM - 6:30PM, 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

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

Equal Employment Opportunity Statement

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.

Benefits and Total Rewards

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.

Compensation

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.