Manager, Laboratory Operations
Millennium Health, based in San Diego, is a leading health solutions company that delivers timely, accurate, clinically actionable information to inform the right treatment decisions for each patient at the right time.
The Manager, Lab Operations is responsible for the testing and reporting of laboratory test results for all CLIA test methods approved by CAP, NY and other regulatory agencies. Responsible for managing the performance of laboratory staff including Clinical Laboratory Scientists.
The following are intended to be examples of the accountabilities for which the person in this position is responsible. This position description is not intended to be complete or all-inclusive and does not preclude management from assigning other or related functions for which the individual has demonstrated competency through performance.
- Required to supervise testing areas and laboratory personnel as required by applicable state and federal regulations
- Expected to review and interpret complex analytical problems
- Responsible for scheduling staff to accomplish production goals
- Responsible for completion of work in their designated area. May delegate responsibilities to qualified staff.
- Responsible for ensuring that Laboratory Occurrence Management (LOM) forms are completed for anomalies; Organizes and implements corrective action as necessary
- Participates in process improvement activities such as quality, safety, document management and control, and proficiency testing
- May interact with vendors on special projects such as test method validations and new equipment.
- Responsible for technical studies designed to improve or validate clinical laboratory testing methods
- Reviews QC records and reports all problems to laboratory operations management
- Assists with advanced troubleshooting issues involving equipment, instruments and assay performance
- Ensures and assists with training, competency assessment, and performance evaluations of laboratory personnel as appropriate
- Writes Laboratory documents such as Standard Operating Procedures and departmental forms as needed and ensures they are current.
- Participates in internal laboratory audits
- Coordinates storage and archive of laboratory information and data
- Collaborates with R&D team to provide guidance on requirements for assay development/transfer into the clinical production laboratory
- Must meet all the requirements of the General Supervisor job description.
- Other duties as assigned.
The Manager, Clinical Operations remains aware of evolving needs and opportunities, showing flexibility to support the Company’s success. Pursues educational opportunities to maintain advanced and up-to-date knowledge in the field. Performs all other related duties as required and assigned and understands that the items in this description are not all-inclusive.
- Bachelor’s degree with current California CLS license (Generalist, Clinical Chemist, or limited Toxicologist Scientist)
- ASCP license highly preferred
- 6+ years in high complexity testing in CLIA/CAP environment
- Supervisory experience required
- Knowledgeable in laboratory methods and techniques, LC-MS/MS highly preferred
- Proficient in MS Applications (Word/Excel/PowerPoint/Outlook)
- Strong interpersonal skills and ability to communicate with all levels of employees
- Effective attention to detail with high degree of accuracy
- Strong verbal and written communication skills
- Demonstrated ability to effectively lead and manage staff
- Must maintain continuing education units required by California Department of Health Services
PHYSICAL & MENTAL REQUIREMENTS
ESSENTIAL PHYSICAL & MENTAL REQUIREMENTS:
This position will require the following physical requirements: sitting (80 %), walking (10 %), standing (10 %), and lifting up to 30 lbs. Physical requirements will vary depending on departmental needs.
This position will require the following mental requirements:
- The employee is expected to read and understand standard operating procedures (SOPs), and is required to follow all safety procedures, policies, precautions, and Quality Assurance
- The employee should be able to convert SOP instructions into work-related tasks.
- The employee must be able to perform simple calculations as required in the SOP
- The employee must be able to use judgment when there is a deviation in the system and effectively communicate any discrepancy to their supervisor.
ADDITIONAL PHYSICAL & MENTAL REQUIREMENTS
- The employee is regularly exposed to high pressure/high stress situations, and therefore, must be able to thrive in this type of environment.
- Must be able to tolerate a moderate noise level.
- Must be able to work an extended schedule as needed.
Millennium Health is an Equal Opportunity/Affirmative Action Employer and E-verify participant. All qualified applicants will receive consideration for employment without regard to race, color, creed, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.