Senior Clinical Laboratory Specialist

Primary Responsibilities

• Identify and communicate daily production, instrument, or test/reagent issues/problems to management
• Ensure the lab is maintained in a clean and organized manner
• Maintain proper PPE sample/material handling; log all incoming materials
• Maintain technical competencies; ensure annual competencies are up-to-date; align annual CE with competencies
• Perform high-/mid-complexity and simple routine tests
• Perform accessioning of clinical samples in the Laboratory Information System (LIS)
• Ensure accurate data transfer and electronic report generation, document final results, submit results for review
• Use LIS effectively to sign-off test completion and communicate results ready for review/release
• Document and report incorrect sample submissions to management; obtain clinical histories; communicate written and verbal reports to clients
• Interview new employees
• Assist with training new employees for routine, moderate, and high-complexity tests; perform competency assessments of all staff; monitor staff performance and report testing issues to management
• Assist in monitoring analyst performance against expectations
• Mentor lab staff to maintain strict adherence to SOPs, Quality System Essentials (QSE), cGMP, and regulatory guidelines
• Perform feasibility studies and assist management in the development of new assays; create drafts of new SOPs
• Assist with strategic project testing; assist in summarizing data
• Participate in validation protocols; assist in the summary of validation data
• Assist management in scheduling laboratory equipment annual calibrations; delegate maintaining laboratory reagent and supplies (inventory) levels to staff
• Utilize Microsoft tools to summarize daily, weekly, and monthly Quality metric data
• Support Leads to document (MediaLab) deviations to SOPs, regulatory requirements, and company policies
• Utilize MediaLab software to enter deviations and CAPA submissions/updates
• Maintain CE credits consistent with laboratory policy

Additional Responsibilities

• Contribute to laboratory organization and appearance
• Maintain inventory in the lab and order reagents as needed

Knowledge, Skills & Abilities

• 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
• Must be able to communicate with all levels of staff and management
• Ability to interface with clients
• Proficient technical writing for regulated documents
• Promotes teamwork and positive employee morale