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

Resilience•West Chester, OH

About The Position

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. The role is primarily non-sedentary and may involve climbing, kneeling, standing, repetitive motion, temperature changes, moving objects with up to 100 pounds of force, and potential exposure to area chemicals. Personal protective equipment may include respirators, PAPR, gowns, gloves, face protection, and other barrier equipment. Employees must adhere to the Quality Management System, Quality Policy, SOPs, cGMPs, and other applicable regulations and standards. The schedule is day shift, 6:00 AM–6:30 PM, on a 12-hour 2/2/3 schedule, with 24/7 on-call support as needed. The company may modify schedules and may request overtime based on business needs.

Requirements

Ability to follow written procedures, SOPs, and work instructions with minimal supervision and escalate issues as needed.
Strong attention to detail and ability to maintain accurate records and perform mathematical calculations.
Ability to effectively read, write, and speak English and follow instructions.
Ability to provide 24/7 on-call support as needed.
Ability to perform the physical activities and work-environment duties described, including using required personal protective equipment.

Nice To Haves

High school, vocational school, or equivalent graduation.
At least 1 year 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 and procedures.

Responsibilities

Document activities, actions, and results according to documentation practices, maintaining accurate and complete records such as laboratory notebooks, quality records, and sample receipts.
Perform visual inspections and routine sampling, including using the Environmental Monitoring System to collect and analyze samples and enter associated data.
Follow SOPs, control documents, and work instructions, and perform laboratory duties consistent with cGMP requirements.
Maintain work areas and equipment in compliance with applicable SOPs and cGMP requirements, and report deviations or non-conformances to a supervisor.
Audit SOPs and work instructions and recommend and initiate activities to keep the area and equipment compliant.
Support the training of new technicians.