Testing Technologist I

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Job Description Summary
Under direct supervision at the Plasma Testing Laboratory, perform high complexity testing of laboratory samples assigned to the department in a fast-paced laboratory. Operate and maintain complex testing equipment. Document and report test results in compliance with departmental procedures while meeting established production demands. Perform all assigned tasks with a high degree of quality and proficiency, all while providing appropriate documentation following CLIA, FDA, EMA, etc. regulatory requirements in a GMP environment. Receives specific direction from supervisor and performs work under the general direction of a technical supervisor.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

Duties and responsibilities regularly performed by and assigned to Testing Technologist levels I, II, and III:

• Accurately and consistently performs assigned laboratory test procedures as outlined in established standard operating procedures.

• Uses proper techniques for sample handling and processing to ensure the validity of test results.

• Conserves laboratory resources by using equipment and supplies as needed to accomplish job results.

• Ensures training qualifications for independent testing are current and accurate.

• Learns complex concepts, technical specifications, and written procedures utilizing a combination of self-paced and hands-on training techniques.

• Adheres to the laboratory's quality control policies: processes controls at defined intervals; evaluates control results; takes appropriate actions to resolve failures, and accurately documents all quality control activities.

• Performs instrument calibrations and maintenance according to established schedules and procedures; verifies successful completion prior to testing.

• Accurately identifies problems that may adversely affect test performance or reporting of test results.

• Maintains technical knowledge of complex automated testing equipment to resolve instrument and analytical errors or testing inconsistencies.

• Reviews test result data for accuracy and compliance to standard operating procedures and regulatory standards prior to release.

• Recognizes invalid test results, takes appropriate corrective action, and documents all findings.

• Follows cGMP regulations and laboratory policies on material handling; make sure reagents/test kits have received dates, expiration dates, and if applicable opened dates.

• Inspects, takes inventory, and stores reagents and supplies when needed. Verifies material expiration dates and takes appropriate actions to limit waste.

• Follows GMP for documentation using ALCOA; ensures that regulations pertaining to records, reports, and data integrity policies are met.

• Documents all errors and corrective actions taken when test systems deviate from the laboratory's established performance specifications.

• 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.

• Disinfects work areas and empty biohazardous waste.

• Follows CLIA, FDA, EMA, and safety guidelines as described in their respective guidelines.

• 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 Testing Technologist levels II and III:

• Performs maintenance tasks on all testing assays and instruments within the assigned department.

• Performs daily checks and monthly review of maintenance logs.

• Logs and tracks operations key performance indicators and provides data to management.

• Supports less experienced testing personnel with resolving technical problems in accordance with laboratory policies and procedures.

• Maintains instrumentation in validated state, tag out and re-qualify instruments when required.

• Identifies and resolves instrument errors, and testing inconsistencies. Escalates problems/delays appropriately.

• Manages result transmission including review and investigation resolution.

• Ensures the department is maintained in a clean and organized manner including proper, sample material and supply storage.

• Verifies and documents acceptable performance of critical testing supplies prior to production use.

• Serves as a resource for corrections and clarification.

• As appropriately delegated laboratory leadership:

• Assists with training staff when the trainer or lead is unavailable.

• Assists with organizing and executing comparison studies, blind sample testing challenges, and linearity verifications.

• Aids new processes/instrumentation implementation by executing verifications and validations.

Additional duties and responsibilities regularly performed by and assigned to Testing Technologist level IIIs:

• Provides subject matter expertise within the department and reviews procedures to ensure compliance.

• Supports the development of new processes by reviewing validations drafts and standard operating procedures.

• Initiates service calls for instrument repairs, coordinates repairs with field services, and assesses re-qualification.

• Performs technical operations review of source testing documentation when needed.

• Documents and investigates incidents of missed maintenance and failed/aborted tests.

• Reviews and approves sample suitability records including sample cancellations.

• Investigates issues related to turnaround time deviations, reactive rates, and instrument failure rates.

• Reviews equipment service reports and accurately identifies the appropriate re-qualification steps to be performed.

• As appropriately delegated laboratory leadership:

• Assists with monitoring laboratory environmental system by addressing and documenting temperature and humidity deviations, may require weekend on-call duties.

• Assists with communicating causes for result invalidation and ensuring proper corrective actions and approvals occur prior to retesting.

• Serves as a primary resource for performing instrument and assay validations.

• When necessary, cross trains in other departments’ processes.

REQUIRED QUALIFICATIONS

• Education: Bachelor’s or higher degree in Biology or Chemistry required , or science related degree where education and training meet CFR 493.1489.

• CLIA requirements for High Complexity Testing required .

• California testing requirements where required by law or SOP.

• Appropriate state licensure and/or certificate, where applicable, required .

• Must possess High Complexity Testing competencies required by Standard Operating Procedures (SOPs), CLIA, and other applicable regulatory and accrediting bodies required .

• Additional Testing Technologist II Qualifications:

• Must possess at least two (2) years of laboratory experience in high complexity testing.

• Must meet the standard for General Supervisor, outlined in 42CFR493.1461.

• Must possess demonstrated advanced laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities.

• Must possess competency on all testing assays and instrument maintenance tasks in assigned department.

• Additional Testing Technologist III Qualifications:

• Must have at least four (4) years of laboratory experience in high complexity testing.

• Must meet the Standard for Technical Supervisor outlined in 42 CFR 493.1449.

• Must be competent on use and maintenance of all instrumentation in assigned shift/department.

• Must possess demonstrated advanced laboratory knowledge and competency in laboratory SOPs and policies to perform job responsibilities.

PREFERRED QUALIFICATIONS

• Certification as a Medical Technologist (MT)/Medical Laboratory Scientist (MLS), Clinical Laboratory Scientist (CL