Testing Technologist

Position: 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…