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Job Field: Office Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

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Requisition Number 12-0689 Post Date 10/29/2012 Title Quality System Product Manager Work Hours 8:00 AM - 5:00 PM Work Schedule Monday - Friday (40 hrs/wk) Department New Technology - 511 City Salt Lake City State UT Description General Function a The PharmaDx Quality System Project Manager works within the New Technology group to coordinate and facilitate all quality and compliance aspects of the groupA??s pharmaceutical projects.aOn the front end, the Quality System Project Manager is essential to the planning and hosting of onsite visits, including quality assessments, audits and inspections.aDuring the life of each pharmaceutical collaboration, the Quality System Project Manager will work to develop, organize and manage important internal documents, such as SOPs, org charts, time accounting logs and invoices.aThe Quality System Project Manager will work closely with each team to implement Design Control principles and will manage associated processes and documents.aThe Quality System Project Manager Coordinator will contribute to the management of FDA submission documents and correspondences.aPost-market, the Quality System Project Manager will participate in important reporting and documentation processes. aReporting Function a This position works under the direction of the Director of the PharmaDx group. aEssential Functions a Establishment of New Pharma Projects a 1.aaaaaFields inquiries to ARUP by pharmaceutical companies regarding laboratory testing services. 2.aaaaaCreates and maintains a log of all pharmaceutical requests. 3.aaaaaAssigns New Technology Group leaders to evaluate requests. 4.aaaaaMakes arrangements for pharma site visits/assessments/audits, including setting up appointments and obtaining necessary agreements such as Nondisclosure Agreements (confidentiality) and Business Associate Agreements (privacy). 5.aaaaaLeads visitors on facility tours, together with ARUP Marketing/Sales Support staff. 6.aaaaaManages visitor review of important documents, procedures and reports via MasterControl, together with Technical Supervisors and Compliance/Quality Systems staff. 7.aaaaaCoordinates ARUPA??s response to quality assessment reports resulting from site visits. a New Test Development/Validation a 1.aaaaaTogether with the PharmaDx Director, drafts test-specific FDA compliant Design Control documents according to plans developed by New Technology Group Project Manager. 2.aaaaaManages test Design History files. 3.aaaaaCollects and organizes all documents generated during test planning, development and validation; documents important milestones . 4.aaaaaDocuments important milestones during test development/validation. 5.aaaaaPrepares reports/summaries on behalf of pharma partners at specified intervals. 6.aaaaaManages time/effort reporting to pharmas; drafts and tracks invoices; records payments. FDA Submission and Post-Market Commitments a 1.aaaaaCollects appropriate FDA submission forms. 2.aaaaaOrganizes test submission documents into master file, including Design Control documents. 3.aaaaaWorks with internal and external contractors to submit tests to FDA as needed. 4.aaaaaFollowing FDA approval or completion of other pharma project, collects documents for annual reporting. 5.aaaaaCollects documents pertaining to test re-validation or test changes. a Other Functions a aA

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