Scientist - Investigator – Analytical Operations

Integrated Resources, Inc

Foster City, California

JOB DETAILS
JOB TYPE
Contractor
SKILLS
Analysis Skills, Clinical Research, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Information Technology & Information Systems, Instrumentation, Interpersonal Skills, Investigative Reports, Laboratory Information Management System (LIMS), Labware, Metrics, Operational Audit, Project/Program Coordination, Regulations, Rehabilitation Nursing, Risk Analysis, Root Cause Analysis, Scientific Data Management System (SDMS), State Laws and Regulations, Technical Writing, Time Management
LOCATION
Foster City, California
POSTED
1 day ago
Scientist - Investigator – Analytical OperationsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionJob Title: Scientist - Investigator (LIS) – Analytical OperationsLocation: Foster City, CADuration: 6 MonthsResponsibilities:Writing Production, Maintenance, Engineering, and Laboratory Investigations focusing on electronic software such as Empower SDMS, LIMS (Labware), ELN (BioVia), and LES (BioVia).Conduct investigations thoroughly to identify all impacts to patients, product quality, validated state, and regulatory complianceConduct root cause analysis to identify all contributing and potentially contributing factors for which led to the deviationPerform risk analysis as needed to determine likelihood and severity of recurrenceAddress impact to systems, processes, product, and any regulatory requirementsWrite laboratory investigation summary reports, deviation reports, and CAPA summary reportsIdentify and develop meaningful and effective CAPAsMonitor completion of lab investigations, deviations, and CAPAsPrioritize and organize laboratory investigations and deviations to ensure timely completionConduct interviews and properly document interviews as appropriate to laboratory investigations and deviationsPerform all technical writing with grammatically correctness, conciseness, accuracy, and completeness with timely completion to meet appropriate deadlinesTroubleshoot instrumentation/test methodsLead/coordinate cross functional projects with limited directionPerform metrics as appropriate for laboratory investigations, deviations, and CAPAsQualificationsKnowledge, Experience and Skills : • 10+ years of experience with BS degree in a relevant scientific discipline or 8+ years of experience with MS degree in relevant scientific discipline • 3 – 5 years of experience in technical writing for deviations and investigations • Strong interpersonal skills that allow for effective communication across functional areas and senior leaders

About the Company

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Integrated Resources, Inc