Description

　　About the Job - (Laboratory Location: Henderson, NC)

　　The Validation Scientist, Blood LCMS, will be responsible for the blood-based LCMS; clinical laboratory testing, validation of new workflows and assays, research and development, and maintaining quality in concordance with CAP requirements. The role will be responsible for training future staff scientists on blood LCMS workflows for daily operations, instrument maintenance, and data analysis. Proficiency with wet lab activities, computers, robotics, and sample tracking as well as researching, developing, and validating workflows are critical to success. This role will also be responsible creating systems and workflows to process patient samples efficiently and effectively in a high throughput and highly regulated environment.

　　MAKO has 20 new LCMS blood based assays that need to be validated and setup to go live with patient testing. The first assays to be validated and setup to go live are Total/Free Testosterone, Estrone, Estriol, Total Estrogens, Vitamin V1, and Vitamin B6.

　　A Day in the Life

　　· Focus on prioritization of wet lab work, for both validations and regular patient testing · Researching and developing new workflows

　　· Design of Experiment for validations

　　· Large scale project management

　　· Writing technical documents (Validations, SOPs, QC, and training)

　　· Building sample trackers and QC parameters for each workflow

　　· Regularly monitoring quality metrics to ensure quality results

　　· Data analysis and organization

　　· Training staff on all aspects of testing

　　· Maintaining and monitoring inventory of reagents and consumables

　　· Delegating responsibilities

　　· Remaining available as a point of contact for Blood LCMS

　　· Communicating and collaborating with direct supervisor and peers to develop and continuously improve workflows

　　· Working with direct supervisor and peers to accomplish tasks

　　· Maintaining a safety centered working environment

　　· Other duties as assigned

　　Requirements

　　What MAKO is looking for

　　· Graduation from an accredited four year college in a relevant field; biology, chemistry, biochemistry, etc.

　　· Experience in clinical diagnostics laboratory wet work 3+ years, preferred

　　· Extensive knowledge of the principles, theories, and practices of LCMS

　　· Specialized knowledge of and ability to use a full range of standard technical equipment, complex scientific apparatus, and automated techniques of analysis

　　· Extensive knowledge of laboratory safety practices and principles

　　· Aware of state and federal laws, rules, regulations, and policies concerning the program area (i.e. CLIA and CAP);

　　· Ability to meet requirements for personnel certification as a technologist pursuant to the Clinical Laboratory Improvement Act (CLIA)

　　· Ability to effectively communicate technical information both verbally and in writing and maintain productive working relationships

　　· Ability to satisfactorily participate in proficiency testing programs and recognize QA problems

　　· Ability to compile, analyze, evaluate, and prepare laboratory reports.

　　· Eagerness to learn and work as part of a team

　　· Positive attitude and willingness to help

　　· Strong communication skills

　　Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

　　The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)