PharmaDx QC Specialist I

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

Department: PharmaDx Group - 511

Primary Purpose:

The PharmaDx Quality Control Specialist I is an entry-level position to provide support to PharmaDx product development program and clinical investigation project teams. The PharmaDx Quality Control Specialist I provides support by reviewing PharmaDx project related data and documentation for accuracy and completeness in accordance with standardized quality control processes and procedures. Identifies erroneous, missing, and incongruous data, calculations and documentation and seeks appropriate and necessary corrections.

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:

Ensures compliance to in-house and external quality control specifications.

Ensures compliance with GDP (good documentation practices).

Performs QC review of reagent preparation documents.

Performs QC review of run folder documentation for clinical investigations.

Performs QC review of development, verification and validation experiment run packets for PharmaDx PDP projects.

Performs QC review of development and validation run packets for bioanalytical assay validations.

Provides constructive feedback to individuals responsible for data and documentation corrections.

Records information in Master Quality Control tracking log.

Maintains QC trackers for individual product development and clinical investigation projects.

Maintains reagent and equipment tracking logs for individual product development and clinical investigation projects.

Performs QC review of data files generated for product development and clinical investigation projects.

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 and effectively communicates 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.

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)