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

RESILIENCE US INC • Fairfield, OH • 3h ago

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 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.

Job Responsibilities

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

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.

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.

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