Laboratory Specialist

About This Role

This role involves providing technical support for clinical and manufacturing operations in a laboratory setting, performing patient molecular/serologic and manufacturing testing, and ensuring regulatory compliance and operational efficiency.

Responsibilities

• Perform duties related to tests, instruments, and reagents
• Identify and escalate potential instrument or reagent problems to Lead
• Maintain the workplace in a clean and organized manner
• Maintain proper PPE, sample/material handling, and log all incoming materials
• Maintain technical competencies and ensure annual CE aligns with competencies
• Perform high-/mid-complexity and simple routine tests
• Ensure accurate data transfer and electronic report generation, document results, and submit for review
• Perform accessioning of clinical samples in the LIS
• Use LIS effectively to sign-off test completion and communicate to management when results are ready
• Report incorrect sample submissions to management and communicate written reports to clients
• Assist with training new employees for routine, moderate, and high-complexity tests and perform competency assessments
• Maintain strict adherence to SOPs, QSE, cGMP, and regulatory guidelines
• Perform feasibility studies and assist management in new assay development
• Assist with strategic project testing and summarize data
• Participate in validation protocols and assist in summarizing validation data
• Perform equipment annual calibrations
• Utilize Microsoft tools to summarize daily, weekly, and monthly Quality metric data
• Support Leads in documenting (Media Lab) deviations to SOPs
• Utilize Media Lab software to enter deviations and CAPA submissions/updates
• Maintain CE credits consistent with laboratory policy

Requirements

• Practical knowledge of immunohematology and molecular procedures, including NAT testing
• Proficient in MS Office Suites
• Excellent organizational skills
• Ability to work on team projects
• Strong written and verbal communication skills
• Ability to communicate with all levels of staff and management
• Proficient in technical writing for inclusion in regulated documents

Qualifications

• Bachelors of Science Degree in immunology, genetics, molecular biology, or related field; CLS (ASCP) or equivalent is a plus
• No previous experience required; twelve months or less of experience in a clinical or research laboratory environment is a plus

Nice to Have

• CLS (ASCP) or equivalent
• Twelve months or less of experience in a clinical or research laboratory environment

Skills

* Required skills