Project control analyst Jobs in Irvine, CA

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Schedule :

Currently 4-10 work hours, with 4 shifts : Sundays- Wed- Days / Swings (7-6 / 1-11) and Wed-Sat - Days / Swings with an overlap on Wednesdays. Seeking candidates who can be OPEN to being flexible in switching their shifts if necessary. Early notice would be provided in the event a switch becomes needed

Responsibilities :

• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
• Execute microbiological and / or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
• Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
• Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
• Assist with monitoring and the control of laboratory supply and critical reagent inventories.
• Perform growth promotion of media and microbial identification testing.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• Provide on call coverage to support oversight of QC laboratory equipment functionality.
• Exhibit proactive communication upon occurrence of compliance risks and deviations
• from laboratory procedures, perform initiation of investigation records within required timeframes.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
• Perform other responsibilities as deemed necessary.

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