Purpose:

Act as a lead for the laboratory quality and technical systems including validation, quality control, proficiency testing, metrology, regulatory, documentation control, and other administrative support services required by the clinical laboratory.

Responsibilities:

– Ensure new hires receive required training and competency and documentation is complete.

– Lead and develop the execution of laboratory technical support, communicates with, and provides guidance and relevant test data to stakeholders.

– Responds to inquiries from other departments and clients requesting specific laboratory/medical information. (i.e., specimen requirements, stability, interferences etc.)

– Develop and lead the clinical laboratory quality control program including statistical analysis, by providing guidance to laboratory staff and communicating with laboratory management, on a monthly basis.
– Ensure that weekly QC has been reviewed.
– Assist in the analysis and troubleshooting of laboratory data.

– Ensure all required assay/instrument documentation is performed and is current.

– Develop and lead in validating (new) assays through developing a validation plan, selection of appropriate statistical acceptance criteria and written summary and acts as a technical specialist for stakeholders in the effective implementation of analytical methods in the lab.

– Develop, lead, and act as contact person on all aspects and phases of proficiency testing and accreditation programs within the local lab.

– Perform metrology in accordance with instrument requirements, record, and file records.
– Perform and/or review pipet calibration and documentation.

– Develop and lead the yearly schedules for the laboratory for regulatory functions and completes data analysis by performing calibration verification/linearity and comparison studies, or other studies as required by various agencies and/or as requested by sponsors.

– Responsible for all system lifecycle activities and associated deliverables pertaining to laboratory instruments and equipment, including the design, testing, and execution of qualification activities, calibration, maintenance, change control and retirement activities, to ensure effective implementation and maintenance of local laboratory instruments and equipment to the highest standard.

– Ensures all regulatory licenses and permits are current and reflect current testing menu.
– Test Code creation and management of the Directory of Services
– Maintain LIS and liaison between users and vendor.
– Initiate, lead, and communicate on a technical level with manufacturers.

– With laboratory personnel initiate the drafting of new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional and global basis.

– Develop and maintain document control system.
– Develop and maintain documentation of compliance to individual training plans.
– Coordinates and tracks CME requirements.
– Prepare QA, safety and other reports as required by Management.
– Represent Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors of the local laboratory.
– Perform each duty in compliance with all regulatory policies and procedures (HIPAA, CLIA,CAP, COLA, NYS, and OSHA)
– Perform other related duties as required.

Required knowledge, skills, and abilities:
– Knowledge of clinical laboratory regulations: CLIA, GA, NYS.
– Knowledge and understanding of CAP, CLSI guideline
– Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures
– Proficiency in PC applications such as word processing, spreadsheets, database management
– Knowledge of metrology
– Excellent attention to detail, organizational skills, verbal, and written communication skills
– Ability to work independently as well as in a team environment.
– Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Minimum Required Education and Experience:

– Bachelor’s degree in life sciences, biological, chemical, or other related field and 3 years relevant clinical laboratory experience; or equivalent combination of education, training, and experience
– Evidence of qualification under CLIA as testing personnel documented.

About Us:
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has more than 17 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com

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Quality Assurance Technical Service Specialist

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