Clinical Laboratory Scientist IV / V / VI, 2nd Shift (Wed - Sat 1:30pm - 12:00am) #4906

Responsibilities

• Perform highly advanced laboratory testing procedures in alignment with established laboratory methods, study protocols, and quality requirements to support clinical research and safety study objectives.
• Prepare and handle complex or specialized samples, reagents, and materials by following detailed workflows that ensure accurate labeling, tracking, and compliance with defined handling requirements.
• Operate and maintain laboratory instruments and analytical systems by performing routine and advanced checks, calibrations, and troubleshooting steps, and reporting equipment issues to assigned personnel for follow-up.
• Record, review, and verify test data in laboratory systems with accuracy, consistency, and adherence to defined documentation and data integrity standards.
• Review assay and quality control results, identify expected and unexpected patterns, and escalate observations requiring additional analysis by senior laboratory staff.
• Perform quality control activities by running controls, documenting deviations, and contributing to the review of quality trends under established laboratory quality expectations.
• Support coordination of study activities by monitoring workflow needs, confirming the availability of materials and equipment, and completing required documentation according to defined timelines.
• Participate in verification or qualification activities related to equipment, methods, or reagent lots by following established procedures and performing assigned tasks with precision.
• Contribute to workflow refinement by identifying routine inefficiencies or procedural questions and communicating observations to senior laboratory personnel to support process clarity and consistency.

Qualifications

• Bachelor’s in MLS or related field; Master’s preferred.
• 5+ years experience in high-complexity molecular diagnostics or equivalent.
• Advanced ASCP or specialist certification strongly preferred.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance.

Preferred Qualifications

• Expert-level molecular diagnostics knowledge.
• Leadership in cross-departmental initiatives and change management.
• Exceptional communication for technical and non-technical audiences.
• Ability to design, execute, and document method validations to regulatory standards.