Quality Technician II, QC Aseptic Hardware

Front Door Defense; Northern (KY); Hybrid; USD 30,000 - 41,000; Full time

Job summary

Resilience is seeking a Quality Technician II, QC Aseptic to perform environmental monitoring and sampling in Class 100/ISO 5 aseptic environments at the WCH site, ensuring accurate cGMP documentation and compliance.

Responsibilities include documenting activities, performing sampling, following SOPs, maintaining clean, compliant work areas, auditing procedures, and assisting training of new staff. Requires 1+ year in pharma/biotech with software proficiency.

Qualifications

• Follow written procedures, SOPs and work instructions with minimal supervision.
• Strong attention to detail and ability to maintain accurate records.
• Proficient reading, writing, and speaking English.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Experience with sampling and testing software such as MODA, LIMS or Novatek.

Responsibilities

• Document activities, actions, and results per documentation practices; maintain complete records.
• Perform visual inspections and routine sampling using Environmental Monitoring System with data entry.
• Follow SOPs, control documents, and work instructions; ensure cGMP compliance.
• Maintain work area and equipment in a compliant state; report deviations or non-conformances.
• Audit SOPs and work instructions; initiate activities to keep area and equipment compliant.
• Support the training of new technicians.

Skills

Environmental monitoring

cGMP compliance

Documentation

LEAN manufacturing

Education

High school or equivalent

Tools

MODA

LIMS

Novatek

Job description

Quality Technician II, QC Aseptic

Perform aseptic environmental monitoring and maintain compliant QC records for sterile manufacturing

Location: West Chester Township, Ohio

Compensation: $22 - 30 USD / hour

About The Role

Quality Technician II, QC Aseptic Control Micro – Aseptic Control Technician

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.

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

• 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.
• 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.
• 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:

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.

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.