Job Functions, Duties, Responsibilities and Position Qualifications:
Position Summary: Responsible for R&D, validation/verification of diagnostic tests, production implementation of tests, and a broad spectrum of troubleshooting in the lab environment. Work closely with management and Medical Leadership to explore, design, evaluate, test, and implement assays and platforms, demonstrate the feasibility of new products and technologies to enhance test menu and reduce costs. Conducts extensive testing in laboratory management systems (LIS), instrument interfaces, databases, and vendor-specific software. Translates projects into Project Management timelines and adheres to delivery dates while being flexible and adaptable to changes. Often solely responsible for implementation of multiple assays and instruments across several departments. Adheres to departmental policies and procedures to include departmental programs, quality control, quality assurance, and safety.
Principle Responsibilities:
- Conducts validation/verification/R&D activities
- Conducts minor research and significant development activities for the validation and verification of new, novel, or improved clinical diagnostic tests, including:
- drafting, editing, and finalizing documentation of activities and results as well as assay documents including SOPs, QC materials and methods, competency exams, and any job forms or worksheets in conjunction with the department Supervisor, Manager, or designee.
- experimental design and execution, including sample cataloging and tracking, planning laboratory work, utilizing a wide range of equipment and methods and possibly including external (e.g. vendor) resources
- troubleshooting of assays, equipment, and/or reagents as required
- validation of spreadsheets and relevant software applications
- data analysis including basic statistics, application of standard curves, and calculation of relevant assay performance metrics
- Leads or facilitates operational implementation of newly developed tests which may include initial training of operations staff, coordinating use of space or equipment, and ongoing assay support
- Estimates and tracks task timelines and adheres to delivery dates using a variety of software tools, maintaining strong communication with relevant stakeholders including Medical Leadership and Medical Directors.
- Leads or facilitates implementation of LIS components associated with tests, including modification and/or testing in the LIS system and documentation of such activities.
- Utilizes job knowledge, judgment, and problem solving skills to ensure quality during the validation process of assay and/or instrument platforms.
- Follows established policies and procedures for quality control performance and documentation.
- Performs and documents scheduled and unscheduled preventative maintenance during the validation process.
- Identifies problems which may adversely affect test performance or reporting of test results and takes appropriate action by communicating concerns to Scientific Director and to the appropriate departmental Supervisor or Manager.
- Understands and follows all safety, infection control, and OSHA Bloodborne Pathogen guidelines.
- Participates in CPL quality assurance programs.
- Participates in the CPL continuing education program and continuing education offered by vendors and/or regulatory agencies.
- Effectively utilizes departmental resources
- Demonstrates efficiency by performing procedures rapidly and determining appropriate priorities daily.
- Utilizes appropriate supplies with minimal waste.
- Operates equipment to maximize efficiency and minimize down time.
- Utilizes unstructured time constructively.
- Utilizes personal and professional skills in effective communication.
- Communicates effectively with all laboratory staff and particularly Medical Leadership to ensure quality patient care.
- Maintains and supports a service oriented relationship with its customers.
- Respects and maintains the confidentiality of information relative to clients and patients.
- Strives to maintain a positive work environment.
This role will have routine access to Protected Health Information (PHI). Employees will be trained on reasonable safeguards and are expected to maintain strict confidentiality, as well as abide by all applicable privacy and security standards.Employees are expected only to access PHI when it is required to fulfill job duties.
Education: BS Degree or higher in Chemical, Biological, or Physical Science.
Certification: None required, but MLS/MT certification preferred
Experience:
Minimum – two years of laboratory training or experience or both.
Preferred – four or more years of laboratory training or experience or both in high complexity and high volume clinical test settings.
Skills: Ability to read, analyze, and interpret technical reports and documents. Ability to write accurate and concise clinical documents, memos, and required correspondence. Ability to collect and analyze data using statistical methods. Ability to communicate effectively at all levels within the laboratory and with laboratory clients and vendors.
Reporting Relationship: Reports to the General Supervisor or other designated manager.
Physical Requirements: Requires light to medium lifting and carrying of objects weighing up to 50 pounds. Requires manipulation of tools, objects, and equipment using the following physical motions: pushing, pulling, lifting, reaching above shoulder height, grasping with both hands, pinching with thumb and forefinger, twisting with hand and wrist, climbing under, lifting up, lifting down, and reaching under. Routinely requires coordination of two or more physical operations. Routinely requires visual discrimination of color, size, shape, and motility. Requires the ability to hear audible alarms on temperature monitored equipment and automated analyzers.
Environmental Demands: Works in temperature controlled environment with constant exposure to biological and chemical hazards. May be required to operate fire and safety equipment or follow other safety procedures in an emergency situation. May be required to work with time constraints and in crisis situations.
Scheduled Weekly Hours:
40
Work Shift:
Job Category:
Laboratory Operations
Company:
Clinical Pathology Laboratories, Inc.
Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.