Company Description Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Duration: 6 Months Investigator (LIS) – Analytical Operations Specific Responsibilities and skills 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 Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (732)-844-8715 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)