Quality Assurance Admin Assistant

Quality Assurance Admin Assistant Scantibodies Laboratory, Inc. - 4.0 Santee, CA Job Details $22 an hour 1 day ago Benefits Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Microsoft Word Spanish Microsoft Outlook Visio English Driver's License Data entry Medical terminology Full Job Description Under the direction of the QA/QC Manager, responsible for administrative support and ensuring that SLI obtains all necessary regulatory approvals and continues to maintain these approvals. Requirements Associates degree or equivalent Bilingual in English and Spanish Good organizational skills and manual dexterity Understanding of medical terminology Accurate data entry skills Good verbal and written communication skills Working knowledge of Outlook, Word, Excel and Visio Valid driver's license, current proof of insurance, and clean driving record Responsibilities Create and maintain facility registrations and any other licenses or required regulatory documents. Maintain a log of all regulatory licenses with appropriate renewal dates Researches regulations and standards for new and existing products to develop regulatory strategies Compiles regulatory submissions such as 510(k) filings, PMA, etc. Reviews CE Marking Technical Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards Reviews Design History Files to determine gaps and any necessary ongoing activities to maintain compliance to current regulations and standards Identify and revise outdated established procedures and assist with revisions of established procedures Correspond with regulatory agencies and individuals by phone, email or fax as appropriate to follow-up on issues as requested Prepare monthly books for QMR Create project plans and act as project manager to implement plans in QA and RA Host facility regulatory inspections and follow-up action results Internet research as requested for regulatory issues Plan fire drills and conduct practical simulations Act as HIPAA Privacy Officer Follow-up on action items to comply with Safety Management System Ensure compliance with blood product lookback requirements Maintain a clean and organized work environment Regular, reliable and predictable attendance May perform other job related duties as assigned May be assigned to any Scantibodies location for any period of time Job Benefits We offer a comprehensive benefits package to include paid sick, vacation, medical, dental, vision, life insurance and 401(k).

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Scantibodies Laboratory, Inc.

is located at:

10946 Woodside Avenue North, Santee, CA 92071 Hiring organization Job Location 9343 Wheatlands Rd., Santee, California, 92071, United States Base Salary $22 Per hour