Job Title: Clinical Laboratory Validation Manager
Reports to: VP of Laboratory Operation
Essential Job Duties: All duties are subject to change by managers during employment. The following is an outline and is not intended to be inclusive of all tasks that could be requested of employee.
Responsibilities and Duties:
- Adhere to and follow laboratory established procedures for processing, analyzing and reporting patient samples.
- Follow laboratory established quality control policies and protocols in recording readings, note deviations and document all corrective actions taken when deviations occur.
- Be capable of identifying problems that may affect test performance and turnaround time and immediately bring it to supervisor or Laboratory directors’ attention.
- Be proficient in a wide range of routine and complex assays performed at AKESOgen with appropriate training.
- Experienced in automated Nucleic Acid instrumentation, SNP genotyping on Illumina and/or Affymetrix platform, DNA/RNA spectrometer, genetic scanners, and other instruments with appropriate training.
- Assist in performing new assay validation and proficiency testing as required.
- Assist in improving quality management and writing/updating SOPs as required.
- Organize and analysis data and help troubleshoot issues with supervisor.
- Understand and follow OSHA, CLIA* and CAP guidelines.
- Plays a key role in maintaining instrumentation and the appropriate documentation for each instrument and assays in their department.
- Demonstrate a high level of ethics in all aspects of professional practice.
- Ensure the accuracy of the information before filing and reported.
- Maintain a clean, safe, and organized lab.
*For individuals listed on CLIA Form CMS-209, please also refer to personnel requirements for Testing Personnel.
PhD with 1 year experience or MS degree in biological sciences with at least 5 years’ experience in a clinical lab setting is a MUST. It is in the hiring manager’s discretion if a candidate has relevant experience or skills to enable him/her to fill this role.
The skills and specifications for this position:
- Affymetrix and/or Illumina platform experience in genotyping is a MUST.
- Excellent analytical abilities and communication skills (verbal and written).
- Excellent practical knowledge about the applications of scientific principles.
- Ability to spot mistakes in procedures and report them to supervisor.
- Ability to work well in a group as well as carry out individual assignments.
- Proficient in computer and internet application skills required for the job.
- Familiar with CLIA and CAP guidelines, great attention to detail.
- Prior supervisory experience will be ideal.
- Adherence to standard universal precautions.
- Exposure to biological and chemical hazards.