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Title:
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DHF Remediation Specialist
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Req #:
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3759
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City:
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Midvale
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State:
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Utah
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Country:
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USA
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Function:
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Quality
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Responsibilities:
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***This is a temporary/contract opportunity for appproximatly 1 year.
Create project schedule to complete DHF remediation and reports against schedule. Work with teams and across departments to assign resources and complete assigned work. Structure ancillary teams such that all appropriate functions are present as needed during the remediation process. Plan and organize activities in support of remediation. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Serve as primary communication hub for team information regarding remediation. Develop and provide guidance for remediation as needed. Organize existing DHF materials. Review and provide assessment on new and existing DHFs based on proceduralized requirements. May review and provide feedback on documents prepared by internal personnel and independent consultants. Work with initiators to rewrite, clarify or reconstruct controlled documents. Coordinate and perform remediation of existing DHFs including: Write justification memos, Write validation/verification protocols and reports, Coordinate required sample preparation and testing, Review, analyze, and report data. Ensure documents are compliant with industry standards and procedures. Ensure consistency in quality assurance review across documents and programs. Integrate various sources of information into a uniform style and language for regulatory compliance. May assist with review and analyses of published literature in relevant therapeutic areas. Coordinate the review, approval, and revision of remediated documents/DHFs. Take ownership for the status of DHF files at ERM.
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Requirements:
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University degree is required, preferably engineering, and a minimum of 2-5 years related experience including medical or scientific writing. Familiarity with basic statistics, laboratory techniques and data analysis is highly desirable.
Excellent communication skills, including the ability to speak, write, and understand English to comply with written procedures, instructions, and regulatory guidance. Must have direct experience interacting and building relationships with team members in various functional areas. A high attention to detail and the ability to work independently are critical, as is the ability to prioritize work on multiple projects and meet all timelines. Must possess the understanding of design controls and record requirements for medical devices. Proficiency with Microsoft Office applications and document formatting templates is required, and experience with document management systems is strongly preferred. Must have experience with in creating and reviewing Design Control deliverables.
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