QA Inspector II
About the role
The QA Inspector II will report directly to the QA Supervisor or QA Manager. This role is responsible for the oversight of all daily QA inspection activities of finished products and sub‑assemblies. The incumbent is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing.
Responsibilities
- Perform in‑process finished goods and final inspection, including visual inspection.
- Verify components against engineering records and documentation requirements.
- Access and interpret engineering drawings, bill of materials, specifications, and purchase orders to determine quality status and support manufacturing.
- Prepare, print, and verify documentation and labels for quality and manufacturing processes.
- Review manufacturing batch records against applicable quality requirements and document inspection results.
- Train new hires.
- Identify and clearly communicate nonconformances to specified requirements to management in a timely manner.
- Proficiently use applicable software to accurately document and maintain the QA inspection process.
- Support completed batch records scanning and records retention.
- Initiate NCMRs for non‑conforming materials and assist in investigations for deviations, corrective actions, etc.
- Ensure compliance with current SOPs and work instructions and suggest enhancements to procedures.
- Review Lot History Records (LHR) for release of finished products and sub‑assemblies in SAP.
- Adhere to all company quality policies and procedures.
Qualifications
- High School Diploma, GED, or equivalent with 3 to 5 years of quality inspection experience required.
- Laboratory or manufacturing setting work experience within a controlled quality environment preferred.
- Ability to work independently once training has been completed.
- Ability to communicate with multiple departments.
- Detail‑oriented to all aspects of daily activities.
- Experience with ISO 9001, ISO 13485, 21 CFR 820 or equivalent QMS standards.
- Maintain a positive and team‑oriented attitude with good organizational skills.
- Good written and verbal communication skills.
- Knowledge of AQL inspection plans.
Benefits
- Paid time off
- Health, dental, and vision insurance
- Retirement benefits
- Flexible spending accounts
Pay
The estimated hourly rate for this role, based in the United States, is between $20.80 / hr and $29.90 / hr. Compensation decisions depend on factors such as individual qualifications, location, internal equity, and market data.