What are the responsibilities and job description for the Quality Assurance Specialist position at TekOne IT Services Pvt. Ltd.?
Role: Quality Assurance Associate III
Location: Marion, NC
Responsibilities
Location: Marion, NC
Responsibilities
- Serve as the Subject Matter Expert (SME) for microbial investigations, managing microbial excursions related to surfaces, viable air, non-viable air, water, bioburden, and endotoxin testing.
- Use TrackWise to oversee investigations and maintain CAPA (Corrective and Preventive Actions) documentation.
- Conduct root cause analysis and implement corrective and preventive measures.
- Lead cross-functional teams in completing investigations and driving process improvements.
- Represent and defend investigations during regulatory inspections.
- Prepare comprehensive technical reports.
- Bachelor's or Master’s degree in Microbiology or a related scientific field.
- Minimum of 2 years of experience conducting root cause investigations within pharmaceutical or medical products.
- At least 5 years of experience in Quality Operations, Microbiology Labs, or Quality Assurance.
