Analytical Operations

Analytical Operations

Investigator (LIS) – Analytical Operations

Duration: 6 Months

Specific Responsibilities and Skills for Position

• Writing production, maintenance, engineering, and laboratory investigations focusing on electronic software such as Empower SDMS, LIMS (Lab ware), ELN (Bio Via), and LES (Bio Via).
• 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

Qualifications

• 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