What are the responsibilities and job description for the Quality Control Specialist position at GroupA?
About the Role
We are seeking a talented Quality Control Specialist to join our team at GroupA. As a key member of our quality control laboratory, you will be responsible for ensuring the highest standards of quality and safety in our products.
- Key Responsibilities
- Perform utilities sampling and environmental monitoring to maintain optimal standards.
- Conduct laboratory testing, including bioburden, endotoxin, sterility, and microbial ID testing.
- Support daily operations such as instrument qualification and maintenance, SOP generation and revision, specification updates, record keeping, and archival.
- Manage the inventory of reagents and supplies for the laboratory.
- Investigate OOS, Out of Trend, deviations, and invalid assays, and implement corrective and preventive actions (CAPAs).
- Participate in qualification activities for microbiological testing and environmental monitoring.
- Validate methods and engage in protocol preparation, execution, and report writing.
Qualifications
- Minimum of 2 years of experience in an FDA-regulated biotechnology or pharmaceutical company.
- Strong expertise in microbiological testing methods and regulations.
- Excellent analytical and problem-solving skills.
