Clinical Laboratory Technologist IV / V / VI #4837 #4838 #4839 #4840 #4841 #4842 ((Night Shift, Wed - Sat, 10:00pm - 8:30am)

Responsibilities:

• Perform testing activities according to established laboratory procedures, study protocols, and quality standards to support clinical research and safety study objectives.

• Prepare samples, reagents, materials, and work areas in accordance with defined workflows, ensuring accurate labeling, traceability, and compliant handling throughout the testing process.

• Operate and maintain laboratory instruments by performing routine checks, calibrations, and basic troubleshooting steps, and report equipment concerns to appropriate personnel.

• Record and verify test data in laboratory systems with accuracy and completeness, following defined documentation practices and data integrity expectations.

• Review assay results for consistency within expected ranges, identify routine inconsistencies, and escalate unusual findings to senior team members for further evaluation.

• Follow established procedures for quality control activities, including running controls, documenting deviations, and supporting routine review of quality trends.

• Support the coordination of study activities by ensuring appropriate sample flow, materials availability, and completion of required documentation according to defined requirements.

• Participate in verification activities for new equipment, procedures, or reagent lots by performing assigned tasks in accordance with established protocols.

• Maintain a clean and organized work environment by following laboratory safety, biosafety, and housekeeping practices required for regulatory readiness.

• Collaborate with team members by sharing information related to task progress, workflow timing, and procedural requirements to support consistent laboratory operations.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

Required Qualifications:

• Bachelor’s degree in a life science field with relevant laboratory experience.

• ASCP MLS/MT or equivalent preferred.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: 

• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

• Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

• Development and Operations within a regulated clinical study environment (e.g.  ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Preferred Qualifications:

• Proficiency in molecular testing workflows and basic troubleshooting.

• Strong time management skills to balance multiple test runs.

• Ability to coach less experienced team members.

• Working knowledge of CLIA/CAP documentation requirements.

Physical Demands and Environment

• Laboratory environment with routine exposure to biological samples and chemicals.

• Requires frequent standing, walking, bending, and occasional lifting up to 40 lbs.

• Mandatory use of PPE (lab coats, gloves, safety glasses) at all times in laboratory areas.

• May require flexible work hours, including evenings, weekends, or holidays, to support operational needs.