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Clinical Laboratory Scientist-Senior Andrologist

IVI America

Clinical Laboratory Scientist (CLS) – Senior AndrologistIVI RMA North America is seeking a full-time Clinical Laboratory Scientist (CLS) – Senior Andrologist to join our growing Andrology Department located in San Francisco, California. The Clinical Laboratory Scientist (CLS) – Senior Andrologist is responsible for performing and overseeing advanced andrology and reproductive laboratory procedures within a fertility clinic setting. This role supports 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.Join a highly specialized fertility team where your expertise directly impacts patients on their family-building journey. Unlike traditional hospital laboratory settings, this role offers a more predictable schedule, limited overnight coverage, and a supportive, collaborative environment focused on reproductive medicine.What We Offer:Predictable and stable schedulingLimited or no overnight coverage requirementsPredictable weekend and holiday rotationsSmaller team environment with greater visibility and collaborationSpecialized reproductive medicine and fertility testingOpportunity to work alongside expert embryologists and fertility specialistsImproved work-life balance and reduced burnout compared to hospital laboratoriesComprehensive benefits package, retirement plan, and generous paid time offThis is an excellent opportunity for an experienced Clinical Laboratory Scientist to grow their career with a global leader in reproductive medicine while making a meaningful difference in patients' lives.PurposeThe Clinical Laboratory Scientist (CLS) – Senior Andrologist serves as the technical and operational leader for the Andrology and Endocrinology Laboratory. This position is responsible for performing advanced diagnostic testing, maintaining regulatory compliance, ensuring laboratory quality standards, supervising laboratory personnel, and supporting fertility treatment through andrology and hormone testing services.All laboratory testing and procedures must be conducted in accordance with laboratory policies, CAP, CLIA, FDA, OSHA, HIPAA, and California Department of Public Health (CDPH) regulations. Attention to detail, technical expertise, leadership, and commitment to quality patient care are essential to success in this role.ResponsibilitiesAndrology Laboratory TestingPerform diagnostic semen analysis according to WHO guidelines and laboratory protocols.Conduct advanced sperm function testing, including:Morphology assessmentMotility and vitality analysisSperm concentration and total motile countDNA fragmentation testing, when applicablePrepare 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:TESAPESAMicro-TESEReview, validate, and accurately report andrology laboratory testing results.Endocrinology & Hormone TestingPerform and oversee reproductive endocrinology testing related to fertility diagnostics.Operate immunoassay analyzers, including Roche Cobas e411, for hormone testing such as:FSHLHEstradiolProgesteroneAMHTestosteronehCGProlactinPerform linearity verification and calibration verification (CALVER) according to laboratory validation protocols.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.Sperm Banking & CryopreservationPerform sperm cryopreservation and thawing procedures for fertility preservation and donor banking.Maintain specimen tracking and chain-of-custody documentation.Ensure compliance with CAP, CLIA, FDA tissue regulations, and CDPH requirements.Monitor cryostorage systems and maintain accurate inventory records.Laboratory Operations & Quality ManagementMaintain 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.Assist with 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.Leadership & TrainingSupervise, mentor, and train andrology laboratory personnel.Ensure staff competency assessments and continuing education compliance.Participate in hiring, onboarding, and performance management activities.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.Clinical CollaborationWork 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.General ResponsibilitiesMaintain patient confidence and protect operations by keeping all patient and proprietary information confidential in accordance with HIPAA requirements.Adhere to all company policies and procedures.Perform other duties as assigned to support laboratory and patient care needs.Academic TrainingBachelor's Degree or higher in Clinical Laboratory Science, Biology, Biochemistry, Medical Technology, or a related scientific field – requiredMaster's Degree in a related scientific discipline – preferredLicensureActive California Clinical Laboratory Scientist (CLS) License issued by the California Department of Public Health (CDPH) – requiredRequirementsMinimum five (5) years of laboratory experience in fertility, andrology, reproductive medicine, or related clinical laboratory environments – requiredExperience performing semen analysis and sperm preparation for ART procedures – requiredExperience performing reproductive endocrinology testing and hormone immunoassay testing – requiredExperience operating and troubleshooting Roche Cobas e411 or similar immunoassay analyzers – requiredAbility 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.Preferred QualificationsExperience working in IVF or Assisted Reproductive Technology laboratories.Familiarity with CAP accreditation standards, CLIA requirements, FDA regulations, and CDPH laboratory regulations.

Vacancy posted 3 days ago
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