- Execute routine QC assays per approved SOPs (HPLC, LC/MS, UV/Vis, qPCR, endotoxin, NGS, etc.) with minimal supervision.
- Prepare and manage samples, reagents, standards, and controls following ALCOA+ principles.
- Maintain instrument cleanliness and perform basic assay troubleshooting; escalate instrument or complex issues.
- Document all work accurately, contemporaneously, and in compliance with GMP and GDP expectations.
- Conduct first-pass data checks for accuracy, completeness, and compliance.
- Assist in drafting deviations, nonconformances, or technical summaries with guidance.
- Contribute to SOP, worksheet, and test method updates under SME direction.
- Support method qualification, execution of method transfer activities, or controlled studies.
- Maintain lab organization, equipment readiness, and material inventory.
- Mentor junior analysts on routine methods and laboratory best practices.
- Perform other duties as assigned.