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 laboratorys 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 laboratorys 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: Bachelors 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 ( -20C) miscellaneous production chemicals moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear garments and gloves. Specific vision abilities required by this job include close vision distance color peripheral vision depth perception and the ability to adjust focus.
• 5 hours per shift: Sitting standing handling. finger dexterity pinching
• 3- 5 hours per shift: Lifting to 20 pounds
• Up to 3 hours per shift: Walking climbing bending squatting reaching above shoulders reaching waist to shoulder reaching knee to waist reaching floor to knee grasping items carrying/move items up to 40 pounds
• Travel: <5%

INTERNAL ADVANCEMENT STATEMENT

In order to be considered for advancement to the next Testing Technologist level employees must possess the required qualifications skills and abilities as stated in the job description AND regularly demonstrate the qualities and behaviors commensurate with our CTS mission vision and values.

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities duties and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability please send an e-mail toto let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

EEO is the Law

EEO is the Law Supplement

Pay Transparency

e-Verify

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Companys established guidelines.