PharmaDx Document Control Specialist

ARUP Laboratories • Salt Lake City, UT

13d • Onsite

About The Position

Maintains and manages the update, review, release, and storage, of all controlled documents in the areas of their responsibility and including some non-controlled documents. Documents may include but are not limited to, policies, processes, standard operating procedures (SOPs), forms, job aides, validations, and batch records to support compliance with ISO, FDA, IVDR, CAP/CLIA, and GMP requirements.

Requirements

• Proficiency in MasterControl software.
• Knowledge of ISO, FDA, IVDR, CAP/CLIA, and GMP requirements.
• Ability to collaborate with subject matter experts.
• Ability to work independently.

Nice To Haves

• Experience in training others on software.
• Experience in performing document control audits.
• Experience in preparing for audits and inspections.
• Experience in document writing.
• Experience in mentoring.

Responsibilities

• Maintains electronic format copies and/or hard copies of approved current revisions of procedures, forms, and supporting documentation for the PharmaDx department through use of MasterControl.
• Provides training as needed in the use of MasterControl within the PharmaDx department.
• Maintains and ensures that all controlled copies and forms are current in the PharmaDx department.
• Performs document control audits as required or assigned.
• Ensures that all controlled documents and test packet reviews are routed on a regular basis, and in accordance with corporate and department standards.
• Manages workflows (collaboration, approvals, and reviews) in MasterControl to ensure appropriate personnel approve and review the documents, as well as monitor document tasks to ensure prompt completion of tasks.
• Ensures documents are named, numbered, and formatted appropriately before uploading to MasterControl.
• Ensures regulatory standards are maintained in the PharmaDx department as it pertains to document control.
• Examines documentation regularly for inconsistencies, gaps, or errors. Collaborates with relevant personnel to ensure accuracy of any revisions. Ensures that any gaps are addressed and resolved.
• Ensures department physical records are scanned and stored properly within their designated area and that records are correctly archived into off-site storage.
• Assists the PharmaDx department quality team in preparation for audits and inspections.
• Prints, prepares, and stores the PharmaDX department controlled batch records for use by the manufacturing team.
• Participates in continuing education and attends the regularly scheduled Document Control Specialist staff meeting and PharmaDx department meetings.
• Trains and mentors other PharmaDx Document Control Specialists as assigned.
• Participates on PharmaDx department project/improvement teams as assigned.
• Presents updates at the PharmaDx department level.
• Participates in document writing as assigned.
• Works with subject matter experts in a positive, collaborative manner to prepare controlled documents which conform to ARUP’s defined format.
• Track, organize, and communicate the PharmaDx department DCS requests and the status of their completion.
• Works independently to accomplish all job duties.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed