What are the responsibilities and job description for the QA Specialist II (Medical Device) position at TekOne IT Services Pvt. Ltd.?
Role: QA Specialist II (Medical Device)
Location: Abbott Park, IL 60064
Duration: 12 Months on W2 (On-Site)
Shift Timings: 8 am to 4 pm
Summary
Location: Abbott Park, IL 60064
Duration: 12 Months on W2 (On-Site)
Shift Timings: 8 am to 4 pm
Summary
- The QA Specialist II is responsible for bioanalytical quality testing within the QIMS and SAP systems. The role involves maintaining the quality system, facilitating CAPA investigations, and overseeing testing events and inventory. This position requires minimal supervision and acts as a point of contact for lab issues.
- Implement and maintain the Quality system.
- Perform quality testing using techniques like HPLC, SDS-PAGE, Western Blot, ELISA, etc.
- Investigate CAPA issues and support quality records.
- Communicate and collaborate effectively with the team.
- Maintain accurate documentation and records.
- Participate in process improvements and product development.
- Ensure compliance with GMPs and GLPs.
- Maintain computer applications relevant to testing.
- Share quality knowledge and train others as needed.
- Manage sample and file storage.
- Ensure lab safety.
- Conduct daily testing and escalate non-conformances.
- Support product technical teams and quality professionals.
- Become an SME in lab certifications.
- Requires basic computer skills.
