Job DescriptionCLIA Lab Manager Job Description:
The CLIA Laboratory Manager is a member of a team responsible for the general upkeep and maintenance of the Eurofins Transplant Genomics CLIA lab (TGI). The Lab Manager oversees all phases of laboratory testing procedures and may also perform Clinical Lab Scientist (CLS) duties as needed. S/he is responsible for documentation of all activities and monitoring compliance with all regulatory and accreditation requirements for the TGI CLIA Laboratory.
The CLIA Lab Manager is responsible for following TGI Laboratory policies and procedures:CLIA Laboratory Manager Job Responsibilities
QualificationsCLIA Laboratory Manager Qualifications:
- Oversees the day-to-day operational issues for the Transplant Genomics Inc (TGI) CLIA Laboratory. Supports the company in the achievement of its goals
- Oversee all lab operations and functions, including proficiency testing, personnel, lab safety compliance, maintains lab operational workflow.
- Develops operational systems in accordance with state and federal guidelines (i.e. Quality Systems, Personnel training & competency, Proficiency Testing, Documentation Systems, Occurrence Management).
- Maintain patient and laboratory records consistent with state and federal regulations.
- Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
- Ensure lab coverage for effective clinical operations. Participate in recruitment and management of clinical lab personnel.
- Ensures compliance and inspection readiness at all times in accordance with federal regulations that apply to the testing facility.
- Works with the Medical Director and Clinical Consultants to create establish and maintain TGI assay performance and development goals. Develops and implements assay Validation parameters, executes Validation testing & other Regulatory requirements in the TGI CLIA Lab.
- Establish and ensure compliance with company policies and procedures: general policies, Exposure Control, Chemical Hazard, Illness and Injury Prevention Program and Quality Assurance Program.
- Monitors equipment maintenance and calibration of laboratory instrumentation to ensure equipment functionality.
- Must possess a valid California CLS license (Generalist CLS or CGMBS license).
- Bachelor's, Master's or PhD degree in life science, Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
- Must qualify as a general supervisor under CLIA 88 Regulations.
- Must possess working knowledge of local, state and federal laboratory regulations that apply to medical diagnostic testing.
- Experience with all phases of developing, validating and implementing high complexity molecular testing in a CLIA environment.
- Technical experience in Molecular Diagnostics, or with Gene Expression Microarrays, Real-Time PCR or Next Generation Sequencing is desirable.
- Experience with preparing for and coordinating laboratory inspections by Federal, State, and other governing agencies.
- Must have excellent interpersonal skills, demonstrated ability to work effectively with multiple disciplines, good team approach, good written and oral communication skills, administrative skills, and above-average computer skills.
- Highly organized, good documentation skills and attention to detail are essential. Results and goals oriented, having integrity, a strong work ethic and a commitment to quality.
- Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
- Effective personal communication skills, shares knowledge with excellent training skills.
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Fremont, CA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Please be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements. Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements 1. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.