Scientist - Investigator – Analytical Operations

Job Title: Scientist - Investigator (LIS) – Analytical Operations

Location: Foster City, CA

Duration: 6 Months

Responsibilities:

• 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 compliance
• Conduct root cause analysis to identify all contributing and potentially contributing factors for which led to the deviation
• Perform risk analysis as needed to determine likelihood and severity of recurrence
• Address impact to systems, processes, product, and any regulatory requirements
• Write laboratory investigation summary reports, deviation reports, and CAPA summary reports
• Identify and develop meaningful and effective CAPAs
• Monitor completion of lab investigations, deviations, and CAPAs
• Prioritize and organize laboratory investigations and deviations to ensure timely completion
• Conduct interviews and properly document interviews as appropriate to laboratory investigations and deviations
• Perform all technical writing with grammatically correctness, conciseness, accuracy, and completeness with timely completion to meet appropriate deadlines
• Troubleshoot instrumentation/test methods
• Lead/coordinate cross functional projects with limited direction
• Perform metrics as appropriate for laboratory investigations, deviations, and CAPAs

Knowledge, 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

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified ™ for Health Care Staffing

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