QA Specialist II - Intellectt INC
Abbott Park, IL
About the Job
Role: QA Specialist II
Location: Abbott Park, IL | Onsite
Duration: 7 Months
Shift: 8 AM to 4:30 PM
Interview: Onsite
Summary:
The QA Specialist II conducts bioanalytical and platform quality testing using WWLIMS, QIMS, and SAP systems. Responsibilities include handling CAPA investigations, managing testing events, maintaining inventory, and ensuring compliance with quality systems. As a Senior Quality Technician, this role operates independently, resolves lab issues, and may assist in scheduling and project management.
Core Responsibilities:
CAPA Investigations: Investigate out-of-specification (OOS) results, manage complaints, and own/approve testing outcomes.
Quality Testing: Perform lab testing in a fast-paced environment, cross-trained in multiple assays.
Process Improvements: Lead and implement process improvements, ensuring GMP and GLP compliance.
System Management: Maintain lab systems and become an SME for key applications.
Quality/Compliance: Support manufacturing and testing, ensure adherence to industry standards, and complete necessary trainings.
Lab Leadership: Lead lab projects, manage sample storage, and ensure lab safety.
Requirements:
- Bachelors or Master's degree in science or related field.
- 2-3 years of experience in quality testing and lab environments.
- Strong GMP, GLP, CAPA knowledge, and advanced skills in Word and Excel.