PharmaDx Document Control Specialist

ARUP Laboratories; Salt Lake City (UT); On-site; USD 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a dedicated Document Control Specialist to manage and maintain essential documentation in compliance with regulatory standards. This role involves ensuring the accuracy and currency of controlled documents, providing training on document management systems, and collaborating with subject matter experts to prepare compliant documents. Join a dynamic team committed to excellence in laboratory services and patient care, where your contributions will play a vital role in supporting healthcare advancements. If you are detail-oriented and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• Maintains and manages controlled documents in compliance with ISO and FDA.
• Ensures all controlled copies and forms are current and performs audits.

Responsibilities

• Maintains electronic and hard copies of current procedures and documents.
• Provides training on MasterControl usage within the department.

Skills

Microsoft Office Suite

Document Control

MasterControl

Education

Associates Degree

Tools

MasterControl

Job description

Building 585
585 Komas Drive
Salt Lake City, UT 84108, USA

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

Department: PharmaDx Quality - 506

Primary Purpose:

Maintains and manages the update, review, release, and storage of all controlled documents in their area of responsibility, including some non-controlled documents. These documents may include policies, processes, SOPs, forms, job aids, validations, and batch records to support compliance with ISO, FDA, IVDR, CAP/CLIA, and GMP requirements.

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 hires top talent to foster a diverse, professional, and growth-oriented work environment. Our team is committed to serving over one million patients each month, striving for excellence and engaging with advances in medicine, recognizing the vital role of laboratory services in patient care.

We seek individuals who value accountability, integrity, service, and excellence. Join our dynamic team.

Essential Functions:

• Maintains electronic and hard copies of current procedures, forms, and supporting documents using MasterControl.
• Provides training on MasterControl usage within the department.
• Ensures all controlled copies and forms are current.
• Performs document control audits as required.
• Routes documents for review and approval per standards, monitoring progress.
• Manages workflows in MasterControl, ensuring proper approvals and timely completion.
• Names, numbers, and formats documents correctly before uploading.
• Maintains regulatory standards related to document control.
• Regularly reviews documents for inconsistencies or errors, collaborating on revisions.
• Properly scans and archives physical records, including off-site storage.
• Assists with audit and inspection preparations.
• Prepares and stores controlled batch records for manufacturing.
• Participates in continuing education and team meetings.
• Trains and mentors other Document Control Specialists.
• Contributes to project and improvement teams.
• Provides updates at department meetings.
• Participates in document writing as needed.
• Collaborates with subject matter experts to prepare compliant documents.
• Tracks and communicates requests and their status.
• Works independently to fulfill all duties.
• Performs other duties as assigned.

Physical and Other Requirements:

• Stooping: Bending body downward and forward at the waist.
• Reaching: Extending hands and arms in any direction.
• Mobility: Moving between work sites and within the office.
• Communication: Effective communication with others.
• PPE: Use of personal protective equipment in a biohazard lab environment.
• Compliance: Adherence to ARUP Policies and Procedures.
• Sedentary Work: Ability to exert up to 10 pounds of force occasionally.

Qualifications

Skills

Behaviors

Motivations:

Education

Required

Associates Degree or higher.

Experience

Required

Basic skills with Microsoft Office Suite.

Preferred

College coursework in technical writing, English, or computer science; laboratory technical background.

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights under federal employment laws. For more information, review the Know Your Rights notice from the Department of Labor.