Labcorp is hiring an APH Manager, Lab Operations to join our team in Torrance, CA!
Work Schedule: Monday-Friday, Day Shift
Job Responsibilities:
Oversee day-to-day operations and on time delivery of testing services for standard and Companion Diagnostic (CDx) activities; manages equipment, instrument and personnel to meet commitments to clients and department goals; engaged in continuous improvement of testing services. Coordinate operations for CDx studies to ensure global efficiency and compliance; develop and implement processes and procedures to improve productivity; resolve operational problems and issues as they arise. Analyze data and metrics to identify trends and areas for improvement. Meets client expectations in delivery of testing services.
Managerial and Leadership duties and responsibilities:
· Provides managerial leadership to the local department staff.
· Communicates the goals and strategy of CLS, the lab and the department
· Manage all day delivery of testing services
· Ensures testing quality and delivery of testing services on time.
· Ensures that an adequate number of trained and competent staff are available to match the workload requirements of the department including administrative workload
· Responsible for ensuring client satisfaction and maintaining good relationships
· Responsible for meeting established quality measures and on time responses to
· Responsible for meeting established quality measures and on time responses to quality issues (QE, PT, QC report, etc.) as required.
CDx studies management
· Works with the principal Investigator to ensure that good clinical laboratory practices are followed and that these are consistent with the aims of the clinical research component for the pharmaceutical sponsor.
· Provide leadership and direction to team members, setting goals and expectations to drive CDx activities.
· Serve as the primary liaison for external Clinical Research Associate, diagnostic sponsor and pharmaceutical sponsor, overseeing the CDx operations for laboratory processes/testing.
· Actively engaged in all activities involving Site qualification visit, Site initiation visit, Initiation and Monitoring Visit and close out visit in collaboration with Principal Investigator and Precision medicine (DDS) team.
· Collaborate with local team, other team and other sites to evaluate and assess new assay capabilities.
· Responsible for global sites alignment for CDx studies
· Decision maker for some process updates for CDx studies globally after consultation to DDS, PI and global director.
· Resolve global operational problems and issues as they arise
· Coordinate with other laboratory teams for study loading (Technical liaison, Pathologist, GSM/RSC/SDL of the Pharma sponsor, ...) to fulfill with specific CDx device sponsor requirement
· Coordinate globally all study documentations for alignment including but not limited to Protocol review (CPSP), IFU, memorandum, SOP
· Attend and represent globally the department for laboratory operation during 3 ways and 2 ways call.
Management:
· Manages all day-to-day production operations of the local department.
· Manages all non-production activities and obligations of the local department.
· Provides support, as required, to the local department leader (director or associate director) and assists in the fulfillment of his/her responsibilities.
· Participates in and supports client visits, site qualification, site initiation and monitoring visits, audits and inquiries to ensure complete fulfillment of requests and interests.
· Responsible for Quality event (QE)/Sponsor finding related to CDx studies and timely investigations and CAPA plans development
Performance Monitoring and Evaluation:
· Ensures quality and timely delivery of both production and non-production activities.
· Monitors and reports performance and results against targets and global standards.
· Ensures regulatory compliance within the local department * Excluding technical review.
· Coordinates departmental activities in support of other functional areas.
· Coordinates departmental activities with Global Laboratory Support Services.
· Assists director in the establishment of globally consistent production standards.
· Ensures on time delivery of performance reports (PT, QC/PM, Internal and External QC) and responses to inquiries from other functional areas.
· Participates in client visits, audits and inquiries; ensures complete fulfillment of requests and audit findings.
· Supports process improvement initiatives.
Personnel:
· Recruits, trains, develops and retains sufficient supervisory resources for the effective oversight of the local department operations
· Converts volume forecasts into specific personnel resource needs and works with the department director (or local associate director) and senior director operations to secure necessary and appropriate personnel in a timely manner.
· Plans, schedules and monitors the technical training and development of local departmental staff.
· Ensures an adequate level of appropriately trained staff is available and effectively assigned to meet the production and non-production requirements of the local department.
Minimum Qualifications:
Six years experience in a laboratory.
Two years supervisory or management experience in a clinical laboratory environment.
Expertise in companion diagnostics.
Qualifications for a technologist and has four years of post-baccalaureate pertinent laboratory experience equivalent to that of an American Society of Clinical Pathologists (ASCP) certified medical technologist, of which not less than two years has been spent working in a clinical laboratory having a director at the doctoral level.
Preferred Qualifications:
· Bachelor's degree of Arts or Science degree in a biological, chemical, or physical science and subsequent to graduation has had and two years of post- baccalaureate pertinent laboratory experience and training equivalent to that of an ASCP certified medical technologist/histotechnologist, of which not less than two years have been spent working in the designated specialty in a clinical laboratory having a director at the doctoral level
OR
· A licensed physician or has earned a doctoral degree in a biological, chemical, or physical science and subsequent to graduation, has had at least two years of post-
baccalaureate pertinent laboratory training and experience equivalent to that of an ASCP certified medical technologist, in a clinical laboratory having a director at the doctoral level
· Professional certification (ASCP, AABB or other) in area(s) of expertise.
Additional Job Standards:
· Fluent in English; Command of French is a plus
· Computer literate.
At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people, and have a drive for service, then Labcorp could be a great next career step!
Pay Range: $75k-$160k
The position is also eligible for an annual bonus under the Labcorp Bonus Plan. Bonuses are payable based on corporate and/or business segment performance and are subject to individual performance modifiers.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please?click here (https://careers.labcorp.com/global/en/us-rewards-and-wellness) .?
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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