Responsible for the implementation, optimization and troubleshooting of clinical laboratory toxicology test methods. Technical Subject Matter Expert (SME) responsible for transfer of assays to the clinical laboratory and technology assessment. Accountable for the performance of laboratory methods and instrumentation.
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.
- Subject Matter Expert (SME) for technical studies designed to improve or validate clinical laboratory testing methods involving immunoassay and LC-MS/MS.
- Serves as liaison to R&D team to provide guidance on requirements for assay development/transfer into the clinical production laboratory.
- Provides guidance and requirements to Business Technology for assessment/implementation/optimization of data analysis software.
- Expected to review and interpret complex analytical problems, responsible for advanced troubleshooting of issues involving equipment, instruments and assay performance.
- Interacts with vendors on special projects such as test method validations and new equipment.
- Provides oversight and ensures proper documentation for all Proficiency Testing/Alternate Assessment activities.
- Writes method validation plans and reports.
- Responsible for ensuring that Laboratory Occurrence Management (LOM) forms are completed for anomalies; Responsible for implementation and oversight of corrective/preventive actions.
- Responsible for process improvement activities involving Quality, Safety, and Standard Operating Procedures; Ensures that SOPs are current.
- Responsible for continuous evaluation/ optimization of test methods for efficiency and cost reduction
- May provide supervision and/or guidance to instrumentation, QC teams and assay transfer/validation personnel. May assist with training, competency assessment, and performance evaluations of laboratory personnel as appropriate.
- Participates in internal laboratory audits.
- Participates in teaching the internal Clinical Toxicology Scientist training program
- Lead/ assist with response to customer complaints requiring in-depth technical assessment and evaluation
- Identify problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately escalate to executive management document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
- Other duties as assigned.
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.
Required Skills
SKILLS/KNOWLEDGE/ABILITIES
- Subject Matter Expert in laboratory methods and techniques, technical proficiency in LC-MS/MS required
- Proficient in MS Applications (Word/Excel/PowerPoint/Outlook)
- Effective attention to detail with high degree of accuracy
- Strong interpersonal skills and ability to communicate (written and oral) with all levels of employees
- Demonstrated ability to effectively lead and manage staff
Required Experience
EDUCATION
- Minimum Bachelor’s degree in medical technology, clinical laboratory science, or chemical, physical, or biological science; Master’s degree or PhD highly preferred
- Current California CLS license (Generalist, Clinical Chemist, or limited Toxicologist Scientist) highly preferred
EXPERIENCE
- 6+ years experience in LC-MS/MS, drug testing/toxicology
- Experience working in a high complexity CLIA/CAP environment highly preferred.
SUPERVISORY EXPERIENCE REQUIRED