Perform QC review of release, stability, and in-process data to ensure GxP compliance.
Review and verify analytical data for drug substance and finished product testing.
QC oversight of analytical methods, assay execution, and troubleshooting (qPCR, ELISA, SEC).
Review SOPs, specs, and documents; support QC procedure improvements.
Review final testing records and documentation prior to release.
Identify and close deviations; lead investigations and corrective actions.

🎯 Requirements

Bachelor’s degree in biology, chemistry, Biochemistry, or related field.
3–5 years’ QC experience at II or III in a bio-pharma lab.
Proficient in QC review of analytical docs and data packages.
Experience reviewing Potency, qPCR, SEC, SDS-PAGE, and DLS.
Knowledge of cGMPs and biotech/pharma regulations.
Excellent interpersonal, communication, and organizational skills.
Proficiency with MS Office and SoftMax Pro.
Viral vector experience is a plus.

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