Quality Assurance Specialist - Biotechnology
JOB DESCRIPTION: Quality Assurance Specialist
Scope of Function: Responsible for the oversight and compliance of all aspects of tests relevant to Microbiology Lab. Under the supervision of Senior QA Manager, performs tasks and duties related to the responsibilities of the Quality Assurance (QA) Department.
Reports to: Sr. Manager Quality Assurance
Specific Duties:
1. Perform executed batch record reviews.
2. Internal and external audit oversight.
3. Review environmental monitoring (EM) data including the quarterly EM trending data.
4. Review all analytical test results relevant to microbiology lab as required (Sterility, Bioburden, LAL, TOC, etc).
5. Assure accuracy of SOPs relating to Microbiology, including creation and revision.
6. Assist in qualification/validation process related to Microbiology.
7. Review and approve incidents, deviations, investigations, change control and OOS as required.
8. Work with colleagues in operations to resolve quality and compliance issues in a timely manner.
9. Serve as the back up to release raw materials and components for the GMP operations.
10. Perform any duties and tasks assigned by Sr. QA Manager
Education and Skills Required:
Education: Four-year college degree in Microbiology or related science is required.
Experience: Must have at least two to three years work experience in GLP/GMP FDA regulated environment. Experience and proficiency in technical writing are also required.
Expertise: Environmental Monitoring of the clean rooms
USP sterility and Bioburden
Endotoxin
USP Water Testing
Total Organic Carbon
Interacts with:
1. Manufacturing and Quality departments.