Scientist (Case Investigation and Resolution)- 12 Month Contract

SUMMARY:
My client based in Salt River, CT is looking for a Scientist

POSITION INFO:

Key Performance Areas:

• The Case Investigation and Resolution department is the Center of Excellence for the resolution of global product complaints. The Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, and ensuring regulatory compliance and optimal levels of customer satisfaction. The ideal candidate has strong technical knowledge, expertise of
• assay workflow and system functionality, enjoys troubleshooting, and has a problem-solving mindset.
• Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.
• Responsible for experimental design of complaint investigations, conducts investigation experiments, and analyzes data using statistical measures for determining a potential product performance issue.
• Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
• Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from complaints.
• Provides information from cases in order to update product documentation.

 Qualifications and Experience Requirements:

• Bachelor’s degree in life sciences, engineering or related field, or equivalent combination of education and work-related experience.
• Proficient in technical writing
• Background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry or related sciences.
• Solid communication skills (written and spoken) in English are essential.
• Work experience in technical product support role, research and development setting, technical customer support role or related function.
• Experience with Molecular Biology techniques, including PCR technology.
• Root Cause analysis knowledge.
• Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485).
• Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).

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