Specimen Processor I

Creative Testing Solutions•San Marcos, TX

4d•Onsite

About The Position

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.

Requirements

High School diploma or equivalent required.
Must be able to speak, read and write in English. Writing must be legible and neat.
Must have basic math and computer skills, effective phone and interpersonal communication skills.
Must have the ability to apply rational thinking and understanding to carry out detailed but uninvolved written and oral instructions.
Must pay attention to detail, have strong organizational skills, and the ability to multitask.
Must possess the ability to deal with problems within the guidelines of standard operating procedures.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to extreme cold ( ≤ -20⁰C), miscellaneous production chemicals, moving machinery and production equipment.
Exposure to high levels of noise on the production floor.
Personal protective equipment required such as protective eyewear, garments and gloves.
Specific vision abilities required by this job include close vision, distance, color, peripheral vision, depth perception and the ability to adjust focus.
5+ hours per shift: Sitting, standing, handling. finger dexterity, pinching
3- 5 hours per shift: Lifting to 30 pounds
Up to 3 hours per shift: Walking, climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, pushing/pulling pallets, carrying/move items up to 40 pounds

Nice To Haves

At least 1.5 years of Specimen Processor experience (for Level II).
Demonstrated laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities defined for the level (for Level II).
At least 3 years of Specimen Processor experience (for Level III).
Demonstrated advanced laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities defined for the level (for Level III).
Accurately identifies problems that may adversely affect equipment, software, or process performance and assist with troubleshooting (for Levels II and III).
Escalates problems/delays appropriately (for Levels II and III).
Maintains technical knowledge of complex automated equipment and manual processes to resolve errors and/or inconsistencies (for Levels II and III).
Investigates issues related to sample receipt, cancellation, resubmission, and pending test requests with minimal supervision (for Levels II and III).
Performs equipment re-qualifications and/or verifications (for Levels II and III).
Performs operations review of source documentation as needed (for Levels II and III).
Conducts employee training when applicable while ensuring training qualifications are current and accurate (for Level III).
Assists the Supervisor and Lead with managing daily workload and providing overall direction of workflow as needed (for Level III).
Reviews equipment service reports and accurately identifies the appropriate re-qualification steps to be performed (for Level III).
Serves as a resource for corrections and clarification (for Level III).
Analyzes, prioritizes and resolves complex equipment problems (for Level III).
Investigates deviations in equipment operations and preventative maintenance (for Level III).
Recommends and implements corrective actions (for Level III).
Assists with competency documentation, records review, and records management (for Level III).
Aids new processes/instrumentation implementation by executing validations (for Level III).
Escalates applicable issues to vendors and ensures appropriate follow-up and resolution (for Level III).
Provides mentorship and guidance to newer staff (for Level III).

Responsibilities

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.