Testing Technologist

Plasma 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 include:

• 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 include:

• 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…