Supervisor Clinical Laboratory # 4798 (Night Shift, Wed - Sat, 10:00pm - 8:30am)

Responsibilities:

• Supervise daily laboratory operations, including sample processing, workflow coordination, and equipment utilization.

• Provide direct supervision, coaching, and performance feedback to laboratory and support staff.

• Verify that personnel are trained and deemed proficient prior to performing testing on patient specimens independently

• Monitor staff adherence to standard operating procedures (SOPs), quality control measures, and regulatory requirements (e.g., CLIA, CAP, OSHA).

• Ensure accuracy and timeliness of sample handling, testing support, and data documentation.

• Initiate preventive and/or remedial actions when test procedures deviate from the laboratory's established performance specifications

• In the event of nonconformances, ensuring that test results are not reported until corrective action has been taken and the test is performing according to laboratory established performance specifications

• Manage scheduling, staffing, and workload distribution to meet operational priorities.

• Direct onboarding, training, and competency assessments for new and existing staff.

• Serve as escalation for troubleshooting complex operational and technical issues, escalating to higher management when necessary.

• Maintain laboratory compliance with safety standards, including PPE use, hazardous waste handling, and emergency protocols.

• Contribute to continuous improvement initiatives, recommending workflow optimizations and efficiency enhancements.

• Prepare and review documentation for audits, inspections, and internal quality reviews.

• Serve as a liaison between frontline staff and laboratory leadership, communicating goals, expectations, and updates.

These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. 

Required Qualifications:

• Bachelor’s degree in a science-related field (preferred), or equivalent combination of education and relevant experience.

• Typically requires 6–8 years of relevant laboratory or technical experience, including prior team lead or supervisory responsibilities.

• Knowledge of laboratory regulations, quality assurance practices, and safety standards.

• 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)

• Strong leadership and people management skills with the ability to supervise, mentor, and motivate staff.

Preferred Qualifications:

• Solid understanding of laboratory operations, sample handling, and equipment use.

• Effective communication skills, both verbal and written, for engaging with staff and leadership.

• Strong organizational and time-management skills with the ability to balance multiple priorities.

• Problem-solving and decision-making skills to resolve technical and operational issues.

• Commitment to maintaining quality and compliance in a regulated environment.

Physical Demands and Working 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.