Description
Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM
Department: PharmaDx - 511
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 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:
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 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.
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.
Qualifications
Education
Required
Experience
Required
Preferred
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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