Quality Technician II, QC Aseptic

Resilience • West Chester, OH

2d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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

Benefits

• annual cash bonus program
• 401(k) plan with a generous company match
• medical
• dental
• vision
• family building benefits
• life insurance
• disability insurance
• paid vacation
• paid holidays
• other paid leaves of absence
• tuition reimbursement
• support for caregiving needs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED