Testing Technologist I

# **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 (CLS) or Medical Laboratory #J-18808-Ljbffr