Laboratory Operations Manager

Summary of position:

Directs, develops, and manages a team that performs medical laboratory tests, procedures, experiments, and analyses via different methods to provide data for diagnosis, treatment, and prevention of disease. Responsible for ensuring a high quality, regulatory compliant, and positive work environment for a fast-paced laboratory.

Duties/Responsibilities:

• Oversees, reviews, teaches, and performs analyses of patient specimens, including urine and blood, to determine the presence of normal and abnormal components.
• Analyzes immunology tests
• Analyzes test results and enters findings in LIMS.
• Performs, records, and reviews quality control to ensure accuracy of clinical data on a daily, weekly, and monthly basis.
• Oversees, reviews, teaches, and performs routine preventative maintenance on assigned instruments and equipment according to established schedule and procedure.
• Verifies instrument function by checking and calibrating specific lab instruments and documents data.
• Review, train, and follow Laboratory Standard Operating Procedures for all tasks.
• Oversee training and competency assessment for staff and provide constructive feedback when team members need additional support.
• Oversee inventory management and provide feedback to procurement team.
• Create content for Standard Operating Procedures for the test methods in place and provide clarity for the team.
• Responsible for department level inspection readiness and compliance with all applicable regulatory requirements.
• Assess workflow, staffing, and operational excellence to meet turnaround time and quality goals.
• Actively participate in the Quality Management program including CAPA and RCA.
• Responsible for preparing department specific quality metrics/key performance indicators.
• Assist with the development of an annual budget as well as department and corporate goals.
• Create and maintain a culture of safety in the department with a focus on training and adherence to protocols
• Maintain a standard of cleanliness in the laboratory and enforce observance among staff.
• Promote inter-departmental communication.
• Participate in cross-functional committees and groups to ensure quality and cohesive progress on corporate goals.
• Oversee quality and acceptance of manufacturing of materials used in patient testing.
• Obtain and maintain applicable ISO or FDA standards.
• Other duties as assigned.

Required Skills/Abilities:

· Must be familiar with lab statistical analysis.

· Must be able to read, interpret, and implement regulatory standards.

· Experience and proficient user of Excel and Word.

· Must be able to lead teams and maintain positive workplace culture.

Education and Experience:

· Bachelor's degree in science or medical technology from a four-year college or university.

· Laboratory experience: 2 year (Required)

· Leadership experience: Preferred

Physical Requirements:

· Prolonged periods sitting at a desk and working on a computer.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Work Location: In person