QC Microbiology Specialist - Validation & Testing

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Syngene International Ltd. seeks a Specialist in Quality Control Microbiology to perform routine sampling and testing, support method transfer, and ensure GLP-compliant operations at a large molecule manufacturing site in Baltimore, MD.

The role collaborates with QA, Manufacturing, Regulatory, and Supply Chain to ensure timely analysis and inspection readiness. The candidate will validate and transfer microbiology methods, investigate deviations, and drive CAPAs, aiming for continuous

Qualifications

• Experience in QC within biologics/pharmaceutical manufacturing.
• Understanding of USDA, USFDA, ICH, EU and Health Canada regulations.
• Audit experience with regulatory inspections and third-party audits.
• Knowledge of biologic techniques and method validation.

Responsibilities

• Perform routine QC microbiology sampling and testing for materials, processes and stability.
• Support development and transfer of microbiology tests and methods.
• Ensure GLP compliance and regulatory documentation is accurate and timely.
• Investigate deviations, OOS/OOT results and CAPAs with root-cause analysis.

Skills

Quality control

Regulatory compliance

Cross-functional collaboration

Leadership

Problem solving

Education

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related

Job description

Syngene International Ltd. seeks a Specialist in Quality Control Microbiology to perform routine sampling and testing, support method transfer, and ensure GLP-compliant operations at a large molecule manufacturing site in Baltimore, MD.

The role collaborates with QA, Manufacturing, Regulatory, and Supply Chain to ensure timely analysis and inspection readiness. The candidate will validate and transfer microbiology methods, investigate deviations, and drive CAPAs, aiming for continuous