Specimen Processor I

# **Job Description Summary** The Plasma Testing Laboratory Specimen Processor is responsible for performing duties relating to sample receipt, sample accessioning and sample processing in a high-volume setting with a high degree of proficiency, all while providing appropriate documentation following CLIA, FDA, EMA regulatory requirements in a GMP environment. **Job Description** **PRIMARY DUTIES AND RESPONSIBILITIES** Duties and responsibilities regularly performed by and assigned to Specimen Processor levels I, II, and III: - Adheres to the laboratory's quality and safety standards maintaining quality control and assurance, as well as ensuring compliance with all applicable regulatory agencies. - Follows cGMP for documentation using ALCOA; ensure regulations pertaining to records, reports and data integrity policies are met. - Receive and process incoming samples in preparation of testing following standard operating procedures (SOPs) as directed by regulatory guidelines. Including processing sample cancellations, sample resubmissions and completing sample reconciliation as dictated by workflow. - Performs sample centrifugation and sample suitability checks utilizing proper sample handling techniques to ensure validity of test results. - Performs equipment maintenance according to established schedules and procedures and maintains associated logs to ensure minimal equipment downtime. - Maintains general cleanliness of department work areas and other laboratory common areas as needed to ensure a clean, safe and professional environment. Accountable for department appearance and organization. - Disinfects work areas and empty biohazardous waste. - Works as a member of a team responsible for completing the Plasma Testing Laboratory daily workload. - Works efficiently to consistently complete heavy workloads while maintaining all quality and safety standards. - Maintains donor confidence and protects the company by keeping information confidential. - Performs all other duties, at the discretion of management, as assigned. - Works periodic over-time, holidays, or weekends as needed. Additional duties and responsibilities regularly performed by and assigned to Specimen Processor levels II and III: - Accurately identifies problems that may adversely affect equipment, software, or process performance and assist with troubleshooting. Escalates problems/delays appropriately. - Maintains technical knowledge of complex automated equipment and manual processes to resolve errors and/or inconsistencies. - Investigates issues related to sample receipt, cancellation, resubmission, and pending test requests with minimal supervision. - Performs equipment re-qualifications and/or verifications. - Performs operations review of source documentation as needed. Additional duties and responsibilities regularly performed by and assigned to Specimen Processor level IIIs: - Conducts employee training when applicable while ensuring training qualifications are current and accurate. - Assists the Supervisor and Lead with managing daily workload and providing overall direction of workflow as needed. - Reviews equipment service reports and accurately identifies the appropriate re-qualification steps to be performed. - Serves as a resource for corrections and clarification. - As appropriately delegated by laboratory leadership: - Analyzes, prioritizes and resolves complex equipment problems. Investigates deviations in equipment operations and preventative maintenance. - Recommends and implements corrective actions. - Assists with competency documentation, records review, and records management. - Aids new processes/instrumentation implementation by executing validations. - Escalates applicable issues to vendors and ensures appropriate follow-up and resolution. - Provides mentorship and guidance to newer staff. **REQUIRED QUALIFICATIONS** - Education: High School diploma or equivalent required. - Additional Specimen Processor Level II Qualifications: - Must…