QC Microbiology Specialist — Biologics & Compliance

Syngene International Limited; Baltimore (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Syngene International Ltd. in the United States is seeking a Specialist – Quality Control Microbiology to join the QC Microbiology team at our large molecule manufacturing site.

The role involves hands-on QC work, sampling and testing, and collaboration with QA, Manufacturing, Regulatory Affairs and Supply Chain to ensure timely analysis and inspection readiness. The successful candidate will have a bachelor’s degree in a relevant science and 5–8 years of QC experience in biologics or

Qualifications

• Bachelor-level scientific degree required in chemistry, biochemistry, chemical engineering or related.
• 5-8 years in QC within biologics or pharma manufacturing for large molecules.
• Understanding of USDA, US FDA, ICH, EU and Health Canada regulations relevant to biologics.
• Experience supporting regulatory inspections and audits.
• Experience leading cross-functional teams and continuous improvement.

Responsibilities

• Perform routine QC microbiology sampling and testing for raw materials, in-process, and finished products.
• Coordinate with QA and other departments to develop and transfer microbiology tests and methods.
• Ensure qualification, validation, and transfer of microbiology methods within QC.
• Investigate QC lab incidents, deviations, OOS/OOT, and CAPA with timely corrective actions.
• Maintain SOPs, IOPs, EOPs, STPs and ensure document control.
• Ensure timely completion of QC activities per project timelines.
• Uphold ALCOA data integrity and participate in internal audits.
• Assist regulatory filings and audit observations resolution.

Skills

Quality control

Cross-functional collaboration

Data integrity(ALCOA)

Regulatory compliance

Leadership

Education

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

Tools

Biologic techniques

Validation of methods

Job description

Syngene International Ltd. in the United States is seeking a Specialist – Quality Control Microbiology to join the QC Microbiology team at our large molecule manufacturing site.

The role involves hands-on QC work, sampling and testing, and collaboration with QA, Manufacturing, Regulatory Affairs and Supply Chain to ensure timely analysis and inspection readiness. The successful candidate will have a bachelor’s degree in a relevant science and 5–8 years of QC experience in biologics or