Overview:
The Laboratory Business and Quality Manager is responsible for overseeing the strategic and operational management of the laboratory’s business processes and quality management systems. This role will focus on ensuring laboratory operations are efficient, compliant with regulations, and aligned with organizational business objectives. The manager will be tasked with driving business development efforts, maintaining the highest quality standards, and overseeing day-to-day laboratory activities to ensure optimal performance and customer satisfaction.

REQUIRED LICENSURE/EDUCATION:

• Bachelor’s degree in Medical Laboratory Science or equivalent
• Certification as an MLS by the American Society for Clinical Pathology (ASCP) or equivalent.

REQUIRED EXPERIENCE:

• At least 5 years of experience in laboratory leadership, quality assurance, or business management, with a focus on laboratory operations.
• Extensive knowledge of laboratory standards and requirements.
• Proficiency in LIS, EMR, data management systems, and Microsoft Office Suite.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with senior management, clients, and regulatory bodies.
• Strong leadership skills with the ability to manage a diverse team.
• Excellent project management and organizational skills.
• In-depth understanding of laboratory quality control processes, equipment management, and compliance regulations.
• Strong analytical skills and ability to interpret data to drive decision-making.

PREFERRED LICENSURE/EDUCATION:

• Master’s degree in Healthcare or Business Administration

PREFERRED EXPERIENCE:

• Proven experience in business development and managing budgets preferred.

EMPLOYEE HEALTH REQUIREMENTS

Exposure to:
Chemicals: Refer to MSDS sheets
Video Display Terminals: Average
Blood and Body Fluids: Exposure is infrequent due to administrative job function.
TB or Airborne Pathogens: Rare, the only risk is that associated with contact with the general public.
Sensory requirements (speech, vision, smell, hearing, touch):
Speech: Needed for presentations, training, telephone communication, facilitating meetings.
Vision: Needed for computer entry, reading memos and literature.
Smell: Needed for electrical/fire safety.
Hearing: Needed for telephone communication, meetings and listening to employee concerns.
Touch: Needed for writing, computer entry, filing.
Activity/Lifting Requirements
Percentage of time during the normal workday the employee is required to:
Sit: 60%
Twist: 0%
Stand: 10%
Crawl: 0%
Walk: 30%
Kneel: 0%
Lift: 0%
Drive: 0%
Squat: 0%
Climb: 0%
Bend: 0%
Reach above shoulders: 1%
The weight required to be lifted each normal workday according to the continuum described below:
Up to 10 lbs: Occasionally
Up to 20 lbs: Occasionally
Up to 35 lbs: Occasionally
Up to 50 lbs: Not Required
Up to 75 lbs: Not Required
Up to 100 lbs: Not Required
Over 100 lbs: Not Required
Describe and explain the lifting and carrying requirements. (Example: the distance material is carried; how high material is lifted, etc.):
Carry reagents to put away for storage, carries reports and paperwork.
Maximum consecutive time (minutes) during the normal workday for each activity:
Sit: 120
Twist: 0
Stand: 30
Crawl: 0
Walk: 30
Kneel: 0
Lift: 0
Drive: 0
Squat: 0
Climb: 0
Bend: 0
Reach above shoulders: 2
Repetitive use of hands (Frequency indicated):
Simple grasp up to 10 lbs. Normal weight:
Pushing & pulling Normal weight:
Fine Manipulation: Calculator, keyboard, writing instruments
Repetitive use of foot or feet in operating machine control: Not Required
Environmental Factors & Special Hazards
Environmental Factors (Time Spent):
Inside hours: 8
Outside hours : 0
Temperature: Normal Range
Lighting: Average
Noise levels: Average
Humidity: Normal Range
Atmosphere: Odors
Special Hazards: Mechanical, electrical, chemical, other - rare exposure to above hazards
Protective Clothing Required: Goggles and mask only as necessary
Pay Range: USD $49.53 - USD $68.20 //H

Business Management:

• Develop and implement business strategies to drive growth and improve profitability of laboratory operations.
• Collaborate with cross-functional teams to identify and evaluate new business opportunities, markets, and client needs.
• Participate in the budgeting, forecasting, and financial performance of laboratory operations, ensuring cost control and efficient resource management.
• Build and maintain strong relationships with clients, stakeholders, and suppliers to ensure smooth operations and business continuity.
• Manage and support the laboratory’s business development efforts, including responding to service requests and negotiating contracts.

Quality Management:

• Oversee the development, implementation, and continuous improvement of the laboratory’s quality management system (QMS), ensuring compliance with laboratory and hospital accreditation requirements.
• Ensure adherence to laboratory and hospital regulatory requirements, such as those set by CAP, COLA and DNV.
• Lead internal audits and inspections to assess compliance with quality standards and to identify areas for improvement.
• Provide training and guidance on quality policies and procedures to laboratory staff.
• Develop and implement corrective and preventive actions (CAPAs) when quality issues arise and ensure proper documentation and resolution.
• Monitor laboratory performance metrics, identifying trends and areas for improvement.
• Develop and enforce standard operating procedures (SOPs) to ensure consistency and accuracy in all laboratory processes.

Team Leadership:

• Manage a team of laboratory professionals, fostering a collaborative and high-performance culture.
• Ensure the continuous development and training of staff to enhance skills and maintain compliance with evolving industry standards.
• Provide regular performance feedback and mentorship to team members, fostering career growth.

As a salaried professional, you may be expected to work above your FTE.
24/7 accountability for department/area.
Demonstrates flexibility with assignments within professional scope/duties/licensure.
Responsibilities: