PharmaDx Document Control Specialist

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 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.

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 ARUPs culture of accountability integrity service and excellence. Consider joining our dynamic team.

Essential Functions:

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.

Work with subject matter experts in a positive collaborative manner to prepare controlled documents which conform to ARUPs 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.

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 including the human body.

Required Experience:

IC