Radius Health, Inc.

  • Quality Assurance Coordinator

    Job Locations US-MA-Waltham
    Posted Date 4 weeks ago(6/24/2019 3:53 PM)
    Job ID
    2019-1979
    # of Openings
    1
    Category
    Quality - Dept
  • Overview

    The QA Coordinator plays an essential role in the management of key GXP (Good Clinical / Manufacturing / Laboratory / Pharmacovigilance / Distribution Practices) Quality Assurance records and documents, including training curriculum management and assignment and Quality Management System records such as deviations, investigations, Audits, Audit Findings, Corrective and Preventative Actions (CAPAs), vendor qualifications and inspections.

    Responsibilities

    • Maintains training requirements matrix, tracking role-based training requirements across the company
    • Assigns training to new and current employees according to the training matrix
    • Tracks and generates compliance metrics on training completion
    • Files training documentation and maintains training files
    • Organizes instructor-led training events, including development of materials, scheduling sessions, preparation of materials and equipment, and logistical facilitation of sessions
    • Tracks development, finalization, release, and retirement of controlled procedures, forms, and templates
    • Tracks, files documentation, and generates metrics on deviations, investigations, and CAPAs
    • Coordinates, tracks, files documentation, and generates metrics for audits
    • Conducts regular quality control checks of documentation related to controlled procedures, training, deviations, investigations, CAPAs, vendor qualifications, and audits
    • Supports regulatory authority inspections, including retrieval, logging, and tracking document requests

     

    Work Environment:

    The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

    Qualifications

    • 1 to 3 years’ experience in the pharmaceutical industry; experience in Quality Assurance a plus
    • Experience with e-learning and electronic Quality Management Systems a plus
    • Bachelor’s degree required
    • Strong administrative skills, including Microsoft Office Suite (PowerPoint, Word, Excel, and Visio)
    • Ability to work independently to solve problems

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