Quality Assurance, Aseptic Technician
Kelly Science, Engineering, Technology & Telecom · Hamilton, OH · 1 mo ago
Science$23–$24/hrFull-time
Location: Cincinnati, OH metro area (onsite). Shift: Night shift 12‑hour rotating, 6 PM–6:30 AM (days off vary week to week). Rate: $23‑24/hour. Duration: 6‑12 months with possibility of extension or permanent placement.
About the Role
We are seeking a detail‑oriented Quality Technician II to support environmental monitoring activities within our sterile pharmaceutical manufacturing facility. The role works independently in both classified (up to Class 100) and non‑classified environments to ensure all processes meet cGMP and regulatory expectations, maintaining a safe, compliant, and high‑performing aseptic production environment.
Responsibilities
- Perform routine environmental monitoring and sample collection in aseptic areas.
- Accurately document all activities and results following Good Documentation Practices.
- Maintain complete laboratory records, quality records, and sample receipts.
- Read and follow SOPs, diagrams, and technical documentation.
- Conduct visual inspections and support cross‑functional operational needs.
- Guide team members on SOPs and work instructions; help coordinate support activities.
- Ensure adherence to cGMP and aseptic techniques across laboratory operations.
- Perform SOP/work instruction audits and assist with continuous compliance improvements.
- Wear required gowning, sterile garments, and PPE in cleanroom environments.
- Provide occasional 24/7 on‑call support.
- Communicate quality or service concerns promptly and constructively.
Requirements
- Experience working in a pharmaceutical production environment, clean‑room setting, tissue manufacturing, or hospital operations.
- Ability to read, write, and communicate effectively in English.
- Strong attention to detail and accuracy.
- Ability to perform basic mathematical calculations.
Preferred Qualifications
- High school diploma, vocational certification, or equivalent required; degree preferred.
- Familiarity with MODA, Microsoft Office, SAP, and KRONOS.
- Experience with LEAN manufacturing practices.
- Knowledge of cGMPs and FDA regulations.
Physical & Work Environment
- Ability to work in cleanroom and aseptic environments with full gowning/PPE.
- Ability to stand, perform repetitive tasks, and complete time‑sensitive activities.
- Regular, reliable attendance and collaboration with cross‑functional teams.
Benefits
- Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, legal plan, and short‑term disability.
- Retirement savings plan.
- Service bonus and holiday pay plans (up to eight paid holidays per benefit year).
- Transit spending account.
- Paid sick leave as required by state or local law.