NAYYIRAH NICHOLAS

● Handle business needs in certain areas such as Purification, Clarification and Buffer

● Works to understand cGMPs

● Completes documentation such as logbooks and BPR's in a timely manner

● Prepare and build equipment for production needs and autoclave machine parts for proper sterilization

● Operate Autoclaves

● SAP usage to maintain inventory level

● Ensures completion of sampling and corresponding documentation as required

● Work in the Batch Record Department

● Ensuring that materials required for production when needed

● Participates in all aspects of production process such as, LIMS, SAP, material ordering, and Labwatch

● Resolve production issues and report to the leadership team

● Complete tasks that corresponds to documentation as required by cGMP

● Complete documentation such as logbooks and BPR's in an timely manner

● Set up operations and troubleshoot production equipment

● Responsible for manufacturing responsibilities in assigned area

● Work with embryos to help create flu vaccine

● Performs production in accordance with volume fluctuation, business need and effective procedures

● Works to understand cGMP's

● Follows effective procedures to ensure the production of a safe and efficacious product

● Works to complete quality documentation (PDR's, logbooks) in a timely manner

● CFR (code of federal regulations) inspection readiness

● FDA audit and understanding and awareness

● Retail and Arcade Attendant

● Extensive customer service skills