PharmaDx Quality Specialist I

ARUP Laboratories; Salt Lake City (UT); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading company in clinical and anatomic pathology is seeking a PharmaDx Quality Specialist I. This role involves supporting the development and production of lab developed tests and ensuring compliance with quality management systems. Ideal candidates will have a Bachelor's degree in Medical Laboratory Sciences and relevant experience in the pharmaceutical or IVD industry. Join us in excellence and accountability in patient care.

Qualifications

• Bachelor’s degree required for PharmaDx Quality Specialist.
• 2 years in pharmaceutical or IVD industry under design control.
• Preferred: 1 year in quality assurance, experience in GMP.

Responsibilities

• Supports development of quality documentation for IVDs.
• Ensures compliance with ISO, FDA regulations.
• Participates in audits and prepares quality assurance documentation.

Skills

Organizational skills

Problem-solving skills

Interpersonal skills

Education

Bachelor's Degree in Medical Laboratory Sciences or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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Primary Purpose

The PharmaDx Quality Specialist I supports the development and production of lab developed tests and companion diagnostics (class III medical devices) under applicable regulations for in vitro diagnostics (IVDs) approval and/or performance of clinical trials. The PharmaDx Quality Specialist I creates, authors, and reviews quality documentation to support the Quality Management System. The PharmaDx Quality Specialist I reports to PharmaDx Quality management and is responsible for supporting preparation of investigation and audit documentation required by ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, and global standards, and for communications to the FDA or other regulatory bodies, as needed. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP), risk management, and current Good Manufacturing Processes (cGMP) and supports associated processes and documents in current and future products.

Schedule

Monday - Friday (40 hrs/wk)

8:00 AM - 5:00 PM

Department: PharmaDx Quality - 506

Primary Purpose

The PharmaDx Quality Specialist I supports the development and production of lab developed tests and companion diagnostics (class III medical devices) under applicable regulations for in vitro diagnostics (IVDs) approval and/or performance of clinical trials. The PharmaDx Quality Specialist I creates, authors, and reviews quality documentation to support the Quality Management System. The PharmaDx Quality Specialist I reports to PharmaDx Quality management and is responsible for supporting preparation of investigation and audit documentation required by ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, and global standards, and for communications to the FDA or other regulatory bodies, as needed. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP), risk management, and current Good Manufacturing Processes (cGMP) and supports associated processes and documents in current and future products.

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 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.

Supports the quality assurance aspects of PharmaDx in order to meet requirements, timelines, and deliverables and to maintain compliance with applicable standards, regulations, and policies.

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

Record review including Batch Record review and product release, Clinical Investigation documentation review, development-related manufacturing documentation, etc.

Supports external audits by sponsors and regulatory authorities.

Supports supplier audits and compliance in accordance to regulatory requirements.

Supports ARUP responses on supplier qualification quality questionnaires.

Supports internal audits of the effectiveness of the PharmaDx Quality Management System.

Supports various validation processes and documentation.

Edits and reviews PharmaDx policies and procedures to ensure compliance with regulations and internal policies.

Participates in continuous improvement projects.

May support onboarding of new team members.

Supports PharmaDx Quality and Regulatory Affairs management in implementing strategic goals for the department and as needed.

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 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.

Qualifications

Education

Required

Bachelor's Degree or better in Medical Laboratory Sciences or related field

Experience

Required

Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or equivalent degree

Two years of experience in pharmaceutical, IVD, or medical device industry working under design control

Preferred

One year of experience in quality assurance

1-2 years of experience in writing quality documents

Experience in Good Manufacturing Practice or Good Clinical Practice

Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint

Demonstrated strong organizational, problem-solving, troubleshooting, and interpersonal skills

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care

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