Technical Specialist 1

The Technical Specialist I serves as an active member of the clinical lab and provides scientific support to ongoing method/assay development and validation. This includes generation of pre-protocol documentation (development/validation plans), conducting experiments, reviewing results, and providing a report on results and conclusions. The Technical Specialist I helps to develop, evaluate, and implement new tests, methodologies, or products for the laboratory under the intellectual and scientific guidance of Laboratory Director and/or Director of Laboratory Operations and/or R&D Scientist. The skills required include Occupational Specific, Technical Skills, Leadership, and Professional.

• Assumes responsibility for improvement of existing methods or implementation of new technology of proven validity.
• Maintains complete and accurate documentation of data generated and work performed.
• Helps in organizing new method validation data, preparation of data for publication and peer review, and participates in formal presentations within EWDx.
• Aids in the investigation, installation, evaluation, and purchase of: laboratory equipment, instrumentation, computer software/hardware, new reagent systems, and other specialty items.
• Participates in the training of laboratory staff in principles of methods and applications within the laboratory. Responsibilities also include addressing customers’ concerns, and developing new tests and services according to the EWDx quality system procedures.

• Responsible for assigned laboratory instrumentation automation improvements and maintenance with strict adherence to regulatory requirements.
• Investigates, recommends, and performs training on laboratory instrumentation and assays.
• Recommends and implements processes for improving or maintaining quality, efficiency, and workflow.
• Coordinates instrumentation purchases and installations.
• Works with IT to set up and validate interfaces for laboratory equipment.
• Programs, troubleshoots, repairs and calibrates laboratory equipment.
• Compiles all required documentation for instrument set up and validation.
• Writes and reviews validation documentation, training checklists, Standard Operating Procedures (SOPs) and preventive maintenance documents.
• Validates new tests/assays/equipment and/or improvements to existing tests, with guidance from the Laboratory Director/R&D Scientist/Manager.
• Coordinates the schedule of and assures performance of routine and non-routine maintenance, maintains inventory of parts, and coordinates service with outside vendors for assigned laboratory equipment.
• Trains other laboratory personnel in operation, programming, maintenance and troubleshooting of laboratory equipment and software as well as assays.
• Trains other laboratory personnel in Good Laboratory Practices (GLP) as well as regulatory and quality guidelines.
• Maintains complete and accurate documentation of data generated and work performed and keeps records in an organized file.
• Sets priorities and meets deadlines in a fast paced and changing environment.
• Maintains expert knowledge of assigned laboratory instrumentation and assays, including laboratory technologist duties and serves as a technical resource.
• Applies the principles, theory, and techniques of GLP to produce and report appropriate clinical laboratory results.
• Understands clinical laboratory testing and workflow/operations. Utilizes this knowledge when developing or optimizing tests/methods for the laboratory.
• Monitors test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
• Participates in Collection Events.
• Records quality investigations and corrective actions, where appropriate.
• Reviews quality control records for shifts and trends and investigates.
• Performs clinical testing as needed.
• Assists/leads making quality controls, solutions, calibrators as needed.
• Performs other duties/projects as assigned by the manager or Laboratory Director..
• Uses a systematic approach in solving problems.
• Analyzes problems and evaluates alternate solutions.
• Uses data in developing solutions to problems.
• Uses appropriate math and statistical problem solving tools.

• Bachelors Degree and/or MLT or MLS with 3-5 years of experience in Clinical Laboratory or an equivalent combination of education and work experience.
• Experience validating assays in a Clinical Laboratory (with CAP/CLIA or New York State accreditation) ideally in Chemistry or  Special Chemistry.
• Experience and strong knowledge of data analysis and interpretation skills.
• Strong communication and collaboration skills as it requires significant interaction with lab staff and management.
• To perform this job successfully, an individual must be able to perform each essential duty competently.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Strong attention to detail.
• Adhere to all applicable confidentiality requirements and Code of conduct set forth by the laboratory.

• As required by Federal, State, or local law.
• Maintain yearly competency in areas assigned.
• May require Background Check and criteria to be met.

• Strong verbal and written skills, communication skills, and interpersonal skills.
• High ability to communicate in English, written and verbally, with all levels of the organization.
• Ability to create and present presentations to groups, large or small.

• Apply the principles, theory, and techniques of Good Laboratory Practices to produce and report appropriate clinical laboratory results.
• Basic math skills and ability to create and work with statistical data

• Moderate to advanced skill level in Microsoft Office Products (e.g., Excel, Word, PowerPoint, etc.) and Adobe Acrobat.
• Ability to perform, create, and interpret statistical data for validations, correlations, etc.
• Ability to quickly learn proprietary software programs (e.g., LIS, MediaLab, Jira, etc.).

This salary range for this position is $80,000 - $90,000 based on the selected candidate's qualifications, market data/ranges, location (ATX or NYC) and internal equity. This position is also eligible for an annual bonus, health, dental, vision & mental health insurance, 401(k) with company match, Flexible PTO, a monthly $100 wellness stipend and various other perks.