Manager, Clinical Laboratory Operations
4 weeks ago
Job summary
The Manager of Clinical Laboratory Operations will be responsible for performing and overseeing high complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.
Responsibilities
* Perform high-complexity molecular testing according to established SOPs, including DNA and
* RNA extractions, NGS library preparation, hybridization-based enrichments, and next-generation sequencing.
* Design and lead lab projects and provide project instruction to technologists
* Mentor and supervise direct reports
* Ensures verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
* Facilitate proficiency testing through the wet lab
* Resolve technical problems and ensure that remedial actions are taken when deviations occur.
* Ensure procedures are reviewed and approved and are followed by all personnel responsible for any aspect of the testing process.
* Evaluate the competency of testing personnel and ensure that the staff maintains competency to perform test procedures and report results promptly, accurately, and proficiently.
* Review quality control documents monthly.
* Review quality assurance and quality control records as needed and serve as a technical resource for the department by investigating and resolving analytical testing problems and recommending a course of action in instances identified as beyond acceptable limits.
* Oversee ordering and maintaining adequate supplies of all reagents and consumables.
* Oversee reagent and assay quality control and validations.
* Perform workflow that maintains quality, thoroughness, and optimum efficiency for Turn Around Time (TAT).
* Utilize the Laboratory Information Management System (LIMS) to track and execute sample processing.
* Document and maintain records and data for executed process steps per Good Documentation Practices (GDP).
* Adhere to safety protocols, such as wearing laboratory coats and required safety gear.
* Maintain organization and cleanliness in the labs.
* Collaborate on SOP revisions and drafts as needed to adjust for process improvement initiatives and regulatory changes.
* Support planning and execution of process development and improvement activities, including LIMS and automation projects.
* Develop a close working relationship with the other technical and scientific staff while collaborating effectively with colleagues from other sections.
Qualifications
* Minimum Bachelor of Science (BS) in Biological or Life Sciences.
* Ability to learn new tasks in appropriate timeframes.
* Excellent attention to detail with experience following precise instructions.
* Well-organized.
* Excellent communication skills.
* Proficiency in Laboratory Information Management System (LIMS).
* Working knowledge in an NGS (Next-Generation Sequencing) environment.
* Knowledge of laboratory safety protocols.
* Experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, SOPs).
* Minimum 8+ years of relevant lab experience in a CLIA/CAP lab.
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