Clinical Laboratory Scientist-Senior Andrologist
IVI RMA GLOBAL · San Francisco, CA · 1 wk ago
AnalystFull-time
Responsibilities
- Perform and oversee advanced andrology and reproductive laboratory procedures within a fertility clinic setting.
- Support male fertility evaluation, endocrine testing, and assisted reproductive technologies (ART) by performing semen analyses, sperm preparation, hormone testing, and laboratory quality management while ensuring compliance with California laboratory regulations.
- Perform diagnostic semen analysis according to WHO guidelines and laboratory protocols.
- Conduct advanced sperm function testing, including: morphology assessment, motility and vitality analysis, sperm concentration and total motile count, DNA fragmentation testing, when applicable.
- Prepare sperm samples for Assisted Reproductive Technologies (ART), including: Intrauterine Insemination (IUI), In Vitro Fertilization (IVF), Intracytoplasmic Sperm Injection (ICSI).
- Process surgical sperm retrieval specimens, including: TESA, PESA, Micro-TESA.
- Review, validate, and accurately report andrology laboratory testing results.
- Perform and oversee reproductive endocrinology testing related to fertility diagnostics.
- Operate immunoassay analyzers, including Roche Cobas e411, for hormone testing such as: FSH, LH, estradiol, progesterone, AMH, testosterone, hCG, prolactin.
- Conduct and document CAP Proficiency Testing (PT) in compliance with CLIA and CDPH requirements.
- Troubleshoot analyzer performance issues and implement corrective actions as needed.
- Perform routine preventive maintenance, calibration checks, and functional verification of instrumentation.
- Monitor assay performance and maintain quality documentation for regulatory inspections.
- Maintain compliance with California Clinical Laboratory licensing regulations.
- Implement and maintain laboratory quality assurance and quality control programs.
- Perform method validation, verification studies, and instrument performance evaluations.
- Auxiliary in preparation for CAP, CLIA, FDA, and CDPH laboratory inspections.
- Maintain laboratory documentation, standard operating procedures (SOPs), and quality records.
- Remain current on laboratory operating procedures, quality systems, regulatory standards, and industry best practices.
- Maintain compliance with OSHA safety requirements and infection control procedures.
- Support laboratory inventory management and cost-control efforts while maintaining high-quality laboratory services.
- Supervise, mentor, and train andrology laboratory personnel.
- Ensure staff competency assessments and continuing education compliance.
- Assist in the development, implementation, and revision of laboratory SOPs.
- Participate in internal audits, regulatory inspections, and laboratory readiness activities.
- Promote a culture of quality, collaboration, and continuous improvement.
- Work closely with reproductive endocrinologists, urologists, embryologists, and nursing staff.
- Provide technical consultation regarding male fertility testing, sperm preparation methods, and endocrine testing results.
- Participate in multidisciplinary patient case discussions and treatment planning.
- Collaborate with multidisciplinary teams to support excellent patient outcomes and achieve laboratory objectives.
Requirements
- Minimum five (5) years of laboratory experience in fertility, andrology, reproductive medicine, or related clinical laboratory environments.
- Experience performing semen analysis and sperm preparation for ART procedures.
- Experience performing reproductive endocrinology testing and hormone immunoassay testing.
- Experience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers.
- Ability to work in a high-volume, fast-paced laboratory environment.
- Ability to communicate clearly and effectively with patients, physicians, and team members.
- Ability to work weekends, early mornings, overtime, and on-call schedules as needed.
- Ability to travel and provide support to satellite laboratory locations when required.
- Excellent organizational, analytical, interpersonal, leadership, and problem-solving skills.
Qualifications
- Bachelor's Degree or higher in Clinical Laboratory Science, Biology, Biochemistry, Medical Technology, or a related scientific field – required.
- Master's Degree in a related scientific discipline – preferred.
- Active California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH) – required.