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An established industry player is seeking a dedicated laboratory manager to oversee daily lab operations and ensure compliance with regulatory standards. This role involves developing quality assurance systems, managing staff, and coordinating clinical trials. The ideal candidate will have a Bachelor's degree in Laboratory Sciences, extensive lab experience, and strong leadership skills. Join a forward-thinking organization that values diversity and provides a supportive environment for professional growth and development.
Summary
Responsible for the daily operation of the lab: staffing, workflow, quality, safety and regulatory compliance. The position is responsible for providing daily management and strategic direction for the laboratories. Ensures compliance with all relevant regulatory agencies including FACT, JC, OSHA, and CLIA.
Does this position require Patient Care?
No
Essential Functions
-Develops and maintains QA systems to ensure high level of performance and effective remedial actions to address deviations from performance specifications.
-Assigns, monitors and supervises work to ensure compliance with laboratory SOPs and applicable federal, state and regulating agencies requirements including health/safety and patient confidentiality.
-Ensures the laboratory is prepared for all regulatory reviews and inspections including Joint Commission and FACT.
-Oversees coordination of clinical trials with principal investigators, study coordinators, quality assurance and compliance.
-Conducts interviews and recommends candidates for hiring according to department policies to ensure adequate staffing for the laboratory.
-Responsible for staff training and education including required department training (safety, infection control, compliance)
Education
Bachelor's Degree Laboratory Sciences required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Medical Technologist (ASCP) - American Society for Clinical Pathology Board of Certification (ASCP-BOC) preferred Histotechnician/Histology Technician [HT(ASCP)] - American Society for Clinical Pathology Board of Certification (ASCP-BOC) preferred
Experience
Lab experience 5-7 years required and Demonstrated leadership experience in hospital-based CLIA laboratory 3-5 years required
Knowledge, Skills and Abilities
- Detailed knowledge of all regulatory requirements including FACT, Joint Commission and CLIA.
- Expert knowledge of laboratory health and safety protocols.
- Effective written and verbal communication skills.
- Strong knowledge of personnel and employment practices.
- Ability to effectively manage staffing levels and workloads.
- Ability to effectively interview and train new employees.
Physical Requirements