Testing Technologist I

Creative Testing Solutions•San Marcos, TX

21h•Onsite

About The Position

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.

Requirements

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 .
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.
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.
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.

Nice To Haves

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 .

Responsibilities

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.
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.
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.
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.
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.