Description

The Laboratory manager assumes the role of clinical embryologist/andrologist while also ensuring compliance in both laboratories with all regulatory agencies, including but not limited to:

American Association for Accreditation of Ambulatory Surgery Facilities
US Food and Drug Administration
New York State Department of Health Clinical Laboratory Evaluation Program
New York State Tissue Bank Resources Program
Society for Assisted Reproductive Technologies
US Centers for Disease Control
College of American Pathologists
American Society for Reproductive Medicine
The Laboratory Manager serves as the quality system manager and has the training experience and authority to provide effective leadership for activities necessary to ensure communication, training, competency assessment, and ongoing compliance monitoring with requirements under the laboratory's quality management system. The laboratory manager reports to the Laboratory Director.

The laboratory manager is responsible for maintaining an organizational plan that consists of a current organization chart, personnel policies, and job descriptions that define qualifications and duties for all personnel, including specimen collection staff, technical staff, supervisors, laboratory managers, administrators, assistant directors, and the laboratory director, as well as the consultants.

The laboratory manager is responsible for maintaining records of the relevant licensure, educational, and professional qualifications, training and experience, continuing education, dates of employment, and competence of all personnel for the duration of employment and six years thereafter.

Able to work as a fully trained clinical embryologist and andrologist performing all duties and tasks required for embryology and therapeutic andrology procedures.
Work well with staff-offering them support and providing them feedback when necessary.
Rotate weekends and holidays as necessary.
Ensuring that all staff adhere to standard operating procedures and the quality management system.
Ensuring proper operation of all equipment and helping staff troubleshoot equipment issues when necessary.
Working with vendors to ensure equipment is appropriately chosen, delivered, installed, utilized, and maintained.
Ability to read, interpret, and clarify regulations to ensure compliance, as well as handle live inspections and correct deficiencies when necessary.
Keeping standard operating procedures and quality management system updated and relevant.
Ensuring regular communication with the laboratory, staff, physicians, ancillary staff, and company management.
Clearly defining, implementing, and maintaining all aspects of the quality management system, including hiring and training new staff, performing regular audits, periodic updating of SOPs, staff competency assessment, retraining staff when necessary, documenting all quality activities appropriately, and maintaining records for a period no less than 2 years.

Requirements

Master's degree or higher in clinical embryology and andrology or related area
Educational, presentation, and listening skills
Working knowledge of Electronic Medical Records and all other software in use
Extensive experience working and supervising clinical embryology and andrology laboratories.
Excellent communication, decision-making, leadership, and problem-solving skills
Excellent follow-through and attention to detail.
Prior familiarization with regulatory agencies, all applicable laws, and guidelines to ensure that these are followed during routine lab operations