Kunal A. Parikh

Led operational and strategic initiatives for clinical testing activities, ensuring regulatory compliance.

• Collaborated with clinical teams to design scientifically sound protocols meeting regulatory standards.
• Translated protocol requirements into actionable workflows, aligning laboratory operations with study deliverables.
• Adapted laboratory methodologies to support evolving clinical needs and product development.

• Implemented Quality Assurance and Control procedures across all instrumentation and methodologies.
• Managed laboratory inventory and resources strategically to minimize disruptions and meet business objectives.

• Instrument validation
• Assist in establishing lab protocols
• Perform technical and complex tasks of work unit including ensuring compliance with state and federal regulations and maintaining laboratory accreditation.
• Implement and maintain the quality assurance program as specified by the Environmental Protection Agency and other regulatory agencies.
• Provide lab training to plant personnel on proper lab methods, procedures, and techniques.

• Led coordination of clinical laboratory operations, aligning services, staffing, and policy implementation to ensure regulatory compliance and operational efficiency.
• Recruited, trained, and managed laboratory personnel, fostering a culture of excellence and accountability across testing and support teams.
• Diagnosed and resolved instrument malfunctions using advanced troubleshooting techniques, minimizing downtime and maintaining workflow integrity.
• Supported assay and instrument validation, ensuring precision and reliability in diagnostic testing through rigorous evaluation protocols.
• Conducted CAP proficiency surveys, reinforcing quality control standards and continuous improvement initiatives.
• Served as key liaison between laboratory and IT departments, streamlining data systems and enhancing interoperability to meet strategic goals.
• Cultivated collaborative relationships with cross-functional teams, promoting open communication and cohesive problem-solving.
• Applied critical thinking to complex challenges, assessing risks, evaluating solutions, and executing informed decisions to optimize lab performance.
• Frequently interacted with physicians to address concerns and complaints regarding test results, ensuring timely resolution and maintaining trust in laboratory services.
• Developed and provided analytical matrices detailing the number of analytes tested and sample volumes, generating actionable reports that helped the business improve turnaround time and maximize profitability.

• Responsible for Hospital laboratory operations including: Performing routine and specialized testing for use in treatment and diagnosis of disease using standard techniques, procedures and equipment in hematology, microbiology, chemistry, serology and urinalysis
• Ensuring all QA and QC is performed, recorded and is within established guidelines
• Follow lab and hospital procedures for specimen handling and processing tests analysis, reporting and maintaining records of patient results
• Participate in training and implementation of new equipment
• Employed microscopic techniques to collect and study blood samples to determine number of cells, morphology and blood group, assessing compatibility for transfusion purposes.