Laboratory Compliance Manager

Job Description

Job Summary:

The Laboratory Compliance Manager will oversee all aspects of regulatory laboratory compliance. The manager will serve as a resource and overseer for the laboratory staff in completing regulatory tasks. The manager will also perform all responsibilities of the Laboratory Technologist.

Essential Duties and Accountabilities:

Designated Quality Systems Manager

Ensures oversight of laboratory quality improvement and quality management.

Maintains CAP/CLIA/NYS compliance, and any other appropriate agencies, within the laboratory and accessioning teams. Ensures compliance with local, state, and federal clinical laboratory regulation and ensures:

Staff understanding and compliance with all regulatory standards

Staff readiness for laboratory inspection

Integration of regulatory changes and new standards

Laboratory Technologist Training and Competency Program is maintained

Obtains and updates State and CLIA licenses for any new tests and technologies

Oversees, reviews, and approves laboratory proficiency testing (PT) surveys

Maintains document control system for the company including original copies, controlled bench copies and controlled/uncontrolled copies within Document Control software

Assists/Oversees laboratory staff in initiation and revision of standard operating procedures (SOPs) for laboratory operation

Maintains documentation of Laboratory Event Management Log and Active Investigation forms

Reviews and approves all laboratory Quality Control (QC) records

Proactively maintains all State laboratory licenses as fully active

Provides educational support for staff members interested in laboratory compliance

Responsible for creating Monthly Quality Report, with participation from each department, and holding Monthly Quality Meeting

Performs all essential duties of the Laboratory Technologist

Performs additional duties as assigned

Education:

Minimum Education: Bachelor's Degree – Molecular Biology, Medical Technology or a related science.

Licensure & Certification: MB(ASCP), MLS(ASCP) certification or equivalent.

Note: Other combinations of formal education, training and experience may be considered

Experience:

3-5 years training and experience in high complexity molecular testing, CAP/CLIA laboratory environment.

Competencies Needed:

Understanding of the basic concepts to maintain CAP/CLIA/NYS regulations over multiple lab locations.

Excellent pipetting skills with extreme attention to detail.

Understanding of general molecular techniques and technologies, including nucleic acid isolations, reagent management, quality assurance/quality control, real time PCR and laboratory information systems.

Must have strong computer skills particularly in Excel, independent worker, dedicated and goal oriented with ability to meet deadlines.

Position requires effective verbal and written communication skills as well as strong people skills.

Must possess visual and audio skills appropriate to complete above listed duties.

Responsive to necessary flexible and/or expanded schedule.

Handles emergency or crisis situations.

Working Conditions:

Physical Demands

Mostly sedentary work

Occasional prolonged standing/walking

Occasionally lifts supplies/equipment

Manual dexterity and mobility

Occasional reaching, stooping, bending, kneeling, crouching

Working Conditions

Exposed to potentially infectious material

May be exposed to toxic chemicals

Subject to hazards of flammable materials

Physical Requirement: The Physical Requirements described herein are representative of those which must be met by an employee to successfully perform the primary functions of this job. Reasonable accommodations may be made to enable individuals with disabilities who are otherwise qualified to perform the primary functions.

Job Classification: Exempt