- Pay: $34-44.82/hr.
- 12-month assignment with possibility for extension or conversion based on performance and budget.
- Review and approve GMP data, including paper and electronic data
- Review audit trails and instrument logbooks
- Hire, train, and supervise data reviewers
- Develop and maintain data integrity program
- Author and review SOPs, manage non-conformance events as needed
- Develop and maintain department metrics on turnaround and right first time Supporting QC during audits and regulatory inspections
- BS or MS degree on biological, chemical sciences, or related discipline, is required.
- 5+ years for BS, 2+ years for MS, 1+years for PhD, of related experience in the
- Pharmaceutical/Biotech industry working in a GMP/regulated environment.
- Strong scientific knowledge and demonstrated analytical background are required.
- Should be familiar with the following assays: SDS-PAGE, Western Blot, SEC, CE-SDS, cell-based assay, qPCR, ddPCR, ELISAs, DLS, compendial assays.
- Excellent understanding to data integrity principle is required.
- Proven experience in analytical instrument is preferred.
- Experience in reviewing audit trail is preferred.
- Experience in lab investigation and deviation is preferred.
- Excellent communication skill is required
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