PharmaDx Quality Control Specialist III

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

Department: PharmaDx - 511

Primary Purpose:

The PharmaDx Quality Control Specialist III is a support role for PharmaDx product development program (PDP) and clinical investigation project teams. The PharmaDx Quality Control Specialist III is responsible for coordinating data and documentation review for all PharmaDx projects. Reviews data and documentation submitted to the PharmaDx Quality Control unit for accuracy and completeness in accordance with standardized quality control processes and procedures.

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 patients 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:

Responsible for all functions of a PharmaDx Quality Control Specialist II.

Develops new QC processes and procedures.

Provides good documentation training and guidance to QC Specialist team and laboratory staff.

Responsible for maintaining the Master Quality Control tracking log.

Assists PharmaDx QC Project Manager with quality control process improvement projects and initiatives.

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.

Continuing Education: Continual assessment of current literature and best practices.

Qualifications

Education

Required

+ High School Diploma or Equivalent or better

Preferred

+ Associates Degree or better

+ Bachelor's Degree or better

Experience

Required

+ High school diploma or equivalent and Four (4) years of quality control/data review experience from a clinical background OR Associates degree in Science or Business related field with Three (3) years of quality control/data review experience from a clinical background OR Bachelors degree in Science or Business related field and Two (2) years of quality control/data review experience from a clinical background

+ Intermediate experience with MS Office 2003+, including Excel, Word, and PowerPoint

+ Strong attention to detail

+ Minimum One (1) year experience in research, clinical laboratory, or medical device industry

Preferred

+ Accurate data entry and data review skills

+ Excellent written and oral communication skills

+ Experience in Good Laboratory Practice and/or Good Clinical Laboratory Practice

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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