Quality Assurance Specialist I, Operations - (Cheyenne, WY)

Job DescriptionSummary:The QA Specialist I reports to the QA Manager. This position is responsible for the oversight of Production Documents assuring compliance to the written procedures and applicable federal regulations (21 CFR - Part 210 & 211, ICH Q7). It is the responsibility of the QA Specialist I to review controlled documents for manufactured products at CLI. The functions of this position include review and disposition of batch records including maintenance of Master Batch Records; and review and approval of Quality Control (QC) raw material analytical data. This position is responsible for the assurance of Good Documentation and Good Manufacturing Practices through document review. It is a requirement of this position to participate in the routine on-call schedule. The functions of this position may include maintenance of Document Control including maintenance of standard operating procedures (SOPs).