QA Specialist II - Intellectt INC
Abbott Park, IL
About the Job
Role: QA Specialist II
Location: Abbott Park, IL
Duration: 07+ Months
Job Description:
The Quality Engineer is responsible for bioanalytical and platform quality testing within systems such as WWLIMS, QIMS, and SAP. This role involves managing product and testing inventories, executing testing events, and supporting CAPA investigations. The Quality Engineer works with minimal supervision and serves as a point of contact for lab issues. As an SME (Subject Matter Expert), the Quality Engineer plays a vital role in lab activities, quality improvements, and ensuring compliance with quality and safety systems.
Key Responsibilities:
- Execute quality testing and approve out-of-specification (OOS) results, investigations, and testing events.
- Collaborate with teams and management to ensure seamless communication and lab operations.
- Maintain and update relevant documents, records, and computer systems.
- Lead process improvement activities within the lab, ensuring compliance with GMPs and GLPs.
- Provide technical support and become a Subject Matter Expert in lab certifications.
- Participate in CAPA investigations, protocol writing, and provide inputs for process improvements.
- Support product development and testing activities in biochemistry and chemistry labs (e.g., Alinity s, ARCHITECT).
- Ensure proper sample and file storage, maintain safety protocols, and participate in lab safety activities.
Required Skills:
- Strong understanding of CAPA processes, OOS results management, and quality systems.
- Ability to work independently and lead lab projects.
- Expertise in bioanalytical testing platforms and SAP, WWLIMS, QIMS systems.
- Advanced skills in Microsoft Word and Excel.
- Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Source : Intellectt INC