Teams at Kashiv BioSciences LLC

Support cGMP compliance for biologics manufacturing by performing inspections, sampling, raw material release, batch and quality event documentation review, walk‑through audits, and corrective action support. Partner with cross‑functional teams to drive continuous improvement and ensure manufacturing and testing meet regulatory and company quality standards. Level of responsibility varies by MQA I–III.

Perform cGMP analytical testing and data verification for clinical and commercial biosimilar products. Troubleshoot protein-chemistry assays (HPLC, SDS-PAGE, CE, ELISA, cell-based bioassays), support release, stability, and in-process testing, lead OOS investigations and CAPAs, author and review QA/QC documentation, collaborate cross-functionally, train analysts, and support audits and regulatory interactions.

Perform incoming inspection, sampling, testing, and release of raw and critical materials; review batch records and quality documentation; support QA investigations (deviations, OOS, change control); perform shopfloor inspections, QA walk-throughs, and cleanroom/laminar hood sanitization; assist project teams to implement corrective and preventive actions and support broader Quality Management activities.