Quality Technician II, QC Aseptic

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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.

• 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

• 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.

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:

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.

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…