Testing Technologist I

Testing Technologist

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.

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 Technician (MLT), Clinical Laboratory Technician (CLT) or equivalent preferred.

Skills and Abilities:

• Must have knowledge of dilutions, ratios, and other basic laboratory math. Strong organization skills and legible handwriting are essential.
• Must speak, read, and write English.
• Must have the ability to apply rational thinking and understanding to carry out detailed written and/or oral instructions, and the capacity to identify and troubleshoot problems within regulatory guidelines and standard operating procedures.

Physical & Travel Requirements:

• Lab work environment: 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