• Quality Assurance Specialist III

    Job Locations US-MA-Bedford
    Posted Date 4 months ago(1/8/2019 10:46 AM)
    Job ID
    2019-1180
    # of Openings
    1
    Category
    Quality
  • Overview

    Ensure the quality of products and compliance to internal procedures and external standards in collaboration with cross-functional teams.  Review, develop, and improve quality system procedures, specifications, and test methods.  Primary responsibility is to oversee change control and related activities including but not limited to deviations, CAPAs, validation. May support investigations of quality issues and perform quality audits as necessary.

     

    Responsibilities

    • Coordinate and lead change control review board meetings
    • Monitor status of change controls and facilitate the approval process and track action items through completion
    • Maintain and continuously improve quality system processes and procedures
    • Review documentation supporting GMP activities for accuracy and completeness
    • Participate on project teams as the QA representative
    • Review and approve validation documentation: URS, plans, protocols, reports
    • Perform investigations of quality issues and implement corrective/preventive actions
    • Perform risk assessments to comply with internal procedures and external guidelines
    • Monitor performance of quality systems and generate reports to communicate status to management
    • Perform other quality assurance duties as assigned

    Qualifications

    • Bachelor’s degree in relevant scientific discipline
    • Minimum five years of experience in pharmaceutical or biotech industry with at least 2+ in Quality Assurance
    • Prior experience working with electronic change control system
    • Prior experience reviewing equipment, utility, and software validations a plus
    • Excellent organizational skills and attention to detail
    • Excellent verbal and written communication, technical writing
    • Strong interpersonal skills and ability to work efficiently on a team
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Ability to make decisions and resolve issues with minimal guidance
    • Knowledge of FDA and international regulations and GxP guidelines

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