Quality Technician, PharmaDx

Ultipro; Salt Lake City (UT); On-site; USD 48,000 - 60,000; Full time

Job summary

ARUP Laboratories, a national clinical and anatomical pathology reference laboratory based in Salt Lake City, seeks a laboratory professional to support PharmaDx Quality and Technical Operations. The role involves preparing specimens, performing waived and moderate complexity analyses, maintaining GDP records, and ensuring proper QC and instrument maintenance.

Strong emphasis on regulatory knowledge (ISO, FDA, CLIA, CAP, GMP) and data handling; associates degree required with preferred

Qualifications

• Associates Degree or better in Clinical Laboratory Sciences or related field.
• Bachelor's Degree in Clinical Laboratory Sciences or related field preferred.
• Two years of experience in a closely related research or clinical lab position.
• Working knowledge of Microsoft Excel and Word.
• Familiarity with regulations and standards (ISO, FDA, CAP/CLIA, GMP, GCP) would be advantageous.

Responsibilities

• Uses routine and specialized automated and non-automated laboratory procedures and/or techniques according to SOPs.
• Performs analytical and decision-making functions with direct supervision.
• Recognizes and reports abnormal results and errors; refers resolution to PharmaDx Quality and PharmaDx Technical Operations.
• Operates and maintains laboratory instruments; conducts minor troubleshooting and calibration as directed.
• Maintains GDP-compliant records and documentation.
• Performs incoming and final material quality control and ensures adherence to guidelines.
• Prepares samples for analysis and assesses sample acceptability.
• Transcribes and verifies data in the laboratory information system.
• Meets turnaround times and participates in training on new procedures.
• Maintains clean work areas and handles reagents and supplies per procedures.

Job description

Schedule :
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM

Department: PharmaDx Quality - 506

Primary Purpose :

Provides services of both a technical and non-technical nature in the PharmaDx Laboratory. Works under the direction of PharmaDx Quality and PharmaDx Technical Operations. Duties include (where applicable under specific state and federal regulations) preparation of specimens for processing in the laboratory; performance of selected waived and moderate complex analytical process; performance and documentation of quality control and selected equipment maintenance/calibration; data handling and input.

About ARUP :

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive. We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions :

Uses routine and specialized automated and non-automated laboratory procedures and/or techniques for which they are qualified, trained, and demonstrate competency according to established lab section operating procedures (SOPs).

Performs analytical and decision-making functions with direct supervision.

Recognizes and reports abnormal results. Recognizes unexpected or implausible results, errors, and problems with analytical methods and testing. Refers resolution to PharmaDx Quality and PharmaDx Technical Operations.

Operates and ensures proper functioning of selected laboratory instruments and equipment. May calibrate selected laboratory instruments to ensure accuracy of results. Performs minor troubleshooting and routine maintenance under direction of PharmaDx Quality and PharmaDx Technical Operations and in collaboration with Laboratory Supervisor. Reports service issues to PharmaDx Quality, PharmaDx Technical Operations and Laboratory Supervisor. Maintain records and documentation adhering to Good Documentation Practices (GDP).

Performs and documents incoming, and final material quality control while maintaining GDP. Refers QC results that fail laboratory criteria to PharmaDx Quality and PharmaDx Technical Operations for resolution.

Understands appropriate sample collection, handling, and transport procedures. Collect samples if required by laboratory section. Prepares samples for analysis and determines acceptability of samples within guidelines. Refers sample issues to PharmaDx Quality and PharmaDx Technical Operations.

Processes data, transcribes results, and verifies data in the laboratory computer system.

Meets lab section turnaround times.

Trains on new procedures to a prescribed level of competency.

Meets output measures as defined by individual group procedures.

Assists others in areas of defined competency when assigned workload is complete.

Performs internal competency testing as directed by PharmaDx Quality and PharmaDx Technical Operations.

Maintains clean and orderly work areas. Cleans bench surfaces and equipment each shift or after contamination or spills.

Performs incoming reagent and supply inspection, acceptance and identification. Notes receipt date and lot number on reagents to ensure that oldest stock is used first.

As assigned, assists in the training of new and existing employees.

Remains informed of all procedures and procedure changes.

Assists in data collection for MFG and QA indicators

Other duties as assigned.

Physical and Other Requirements :

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Qualifications

Education

Required

Associates Degree or better in Clinical Laboratory Sciences or related field.

Preferred

Bachelor's Degree or better in Clinical Laboratory Sciences or related field.

Experience

Required

Associate’s degree in clinical or medical laboratory science, medical technology, or in the chemical or biological sciences plus two years of experience in a closely related research or clinical lab position

Working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards) to support associated cGxP processes and documents for current and future companion diagnostic tests and to support clinical trials

Possesses a working knowledge of Good Documentation Practices, Good Manufacturing Processes, and quality change control

Working knowledge of Microsoft Excel and Word

Demonstrated skill in routine and complex laboratory techniques

Demonstrated experience in performance and documentation of quality control functions, equipment maintenance and data handling and input

Preferred

Bachelor’s degree in clinical or medical laboratory science, medical technology, or in the chemical or biological sciences plus two years of experience in a closely related research or clinical lab position

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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