Job Title: Clinical Laboratory Scientist

Job Description

We are seeking a dedicated and skilled Clinical Laboratory Scientist to join our team. This role involves ensuring the accuracy and efficiency of laboratory operations, maintaining high standards of analytic performance, and adhering to established quality control policies. The ideal candidate will have experience in laboratory procedures and a commitment to excellence in clinical testing.

Responsibilities

• Follow the laboratory’s procedures for specimen handling, labeling, processing, transportation, and storage.
• Monitor test performance and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
• Adhere to the laboratory's quality control policies and document all quality control activities, instrument and procedural calibrations, and maintenance performed.
• Follow established policies and procedures whenever test systems are not within acceptable levels of performance.
• Document corrective actions taken when test systems deviate from established performance specifications.
• Open shipping packages containing human medical specimens.
• Prepare, test, qualify, and store reagents accurately.
• Transcribe handwritten and printed documentation onto worksheets and into laboratory information systems.
• Participate in the review of SOPs, forms, logs, or other documents.
• Develop and/or author SOPs and other regulatory documentation.
• Assist in the training of new personnel.
• Assist in the development of new clinical tests.
• Transmit patient results to clients as needed.
• Participate in the performance review process for others.
• Attend and participate in intra- and interdepartmental meetings as required.
• Maintain records that demonstrate proficiency testing samples are tested in the same manner as patient specimens.
• Ensure patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
• Perform all duties in keeping with company’s core values, policies, and applicable regulations.
• May function as laboratory point person for incoming R&D or pharma projects.

Essential Skills

• Diagnostic assays and validation.
• Three years of laboratory experience in high complexity testing.
• Experience in a diagnostic start-up environment.
• Writing and performing validations.
• Excellent communication, interpersonal, and problem-solving skills.
• Highly organized and detail oriented.
• Self-directed and accountable.

Additional Skills & Qualifications

• Experience with protein or molecular testing preferred.
• Experience with development and assay validation processes preferred.
• Experience with ISO/FDA/CE highly desired.
• Experience with Design Controls.
• Bachelor’s degree in science (chemical, physical or biological science or Medical Technology from an accredited institution).

Work Environment

The work environment is centered on laboratory operations, involving the use of diagnostic assays and validation processes. The role requires adherence to regulatory standards and company policies. You will collaborate with intra- and interdepartmental teams, and may participate in R&D or pharma projects. This position demands a detail-oriented and organized approach, ensuring all tasks are completed to a high standard.