- Oversee the overall operations of the Clinical Laboratory including, but not limited to ensuring test systems are functioning properly, monitoring patient and quality control testing results, planning, validation and implementation of new test procedures, and supervision of laboratory personnel.
- Work with other laboratory personnel on the laboratory's quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training
- Manage stability studies, validation protocols, and other process improvements and new assay projects.
- Review validation and stability study protocols and technical reports.
- Write and review standard operating procedures.
- Provide direct supervision to testing personnel.
- Perform analytical procedures including testing, quality control, preparation and aliquoting of reagents and analyses according to the laboratory's standard operating procedures.
- Operate and maintain laboratory instruments and equipment according to laboratory standard operating procedures
- Troubleshoot and problem solve instrument issues.
- Check, monitor and record temperature and perform root cause analysis of deviations and implement a resolution or initiate a service request as necessary.
- Review, interpret and report patient results as assigned.
- Resolve high complexity problems that adversely affect the test performance.
- Perform, review and document laboratory quality control procedures.
- Perform and document reagent qualifications per the approved protocols.
- Resolve all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
- Participate in the introduction of assay improvements, new assay configurations and validation.
- Participate and comply with Quality and applicable regulatory requirements.
- Participate in cross-functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the GRAIL Clinical Laboratory, including compliance with all applicable standards and regulations.
- Communicate effectively with coworkers and non-laboratory personnel.
- Conduct performance reviews of supervisors and laboratory personnel.
- Maintaining records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
- Perform other laboratory and administrative duties as needed.
- Bachelor of Arts or Bachelor of Science in Biomedical Laboratory Science, Clinical Science or related field or equivalent
- Experience in molecular biology techniques preferred
- Working knowledge of local, state and federal laboratory regulations preferred
- 7+ years of Laboratory experience or equivalent
- 4+ years of people management experience, 2 years of which directly managing people leaders (supervisors) required.
- High volume laboratory experience preferred
- Outstanding professionalism, leadership and communication skills
- Strong analysis, problem solving skills and project management skills
- Strong technical skills and job and industry knowledge
- Able to integrate and apply feedback in a professional manner
- Able to prioritize and drive to results with a high emphasis on quality
- Ability to effectively communicate technical information to technical and non-technical audiences
- Ability to work as part of a team within a highly collaborative environment
- Strong computer skills
- Ability to analyze and solve complex issues that impact the performance of the assay
- Ability to proactively communicate consistently, clearly and honestly
- Ability to prioritize tasks with a high emphasis on quality
- Flexibility of work schedule to meet the needs of GRAIL's Clinical Laboratory
- Hours and days may vary depending on operational needs
- Standing or sitting for long periods of time may be necessary
- May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation
- Repetitive manual pipetting may be necessary
- Some lifting (up to 25 pounds) may be necessary
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Manager Clinical Laboratory - Raleigh, United States - GRAIL, Inc.
Description
GRAIL is seeking a Clinical Laboratory Manager to support our clinical lab operations in RTP. This role will be responsible for the overall operations of the Clinical Laboratory including, but not limited to ensuring test systems are functioning properly, monitoring patient and quality control testing results, planning, validation and implementation of new test procedures, and supervision of laboratory supervisors. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, strong leadership skills, experience managing people leaders, ability to multitask, be flexible with tasks and schedules, and the ability to work independently in a team environment.
The Clinical Laboratory Manager must also act as a liaison between the laboratory staff and crossfunctional Management groups. As such, the Clinical Laboratory Manager must exhibit leadership skills with good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure, effective interpersonal skills, and the ability to effectively communicate across all levels of the laboratory and across departments. The Clinical Laboratory Manager will also be involved with scheduling, troubleshooting high complexity technical and non-technical problems, coaching and mentoring the laboratory supervisors, building effective teams, managing projects, meeting project deliverables, and understanding and implementing laboratory goals. Given the wide variety of tasks involved in this position, the Clinical Laboratory Manager must demonstrate the ability to analyze complex issues and make sound decisions in a timely manner, commitment to helping and motivating employees, the ability to respond to difficult issues quickly, fairly, and ethically, outstanding organizational skills, the ability to respond to change with flexibility and to adapt quickly to evolving circumstances, excellent communication skills including utilizing various communication channels (team meetings, one on one's, etc.), proactively communicating team goals and priorities clearly, openly and objectively, and communicating changes, issues, and challenges in all directions of the organization.
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