• Quality Assurance Specialist III

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(1/8/2019 10:46 AM)
    Job ID
    # of Openings
  • Overview

    Works with other departments to ensure the quality of products and compliance to internal procedures and external standards. Reviews records from production and testing and records for product development. Reviews, develops, and improves quality system procedures, specifications, and test methods. Provides oversight for elements of the quality system such as change control or deviations. May support investigations of quality issues or perform quality audits.


    •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
    •Coordinate change control review board meetings
    •Monitor status of change controls and facilitate the approval process
    •Perform investigations of quality issues and product complaints and implement corrective/preventive actions
    •Perform risk assessments to comply with internal procedures and external guidelines
    •Assist with internal audits and supplier audits as needed
    •Monitor performance of quality systems and generate reports to communicate status to management
    •Perform other quality assurance duties as assigned


    •Bachelor’s degree in relevant scientific discipline
    •Minimum five years of experience in pharmaceutical or biotech industry
    •Prior experience reviewing equipment, utility, and software validations
    •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


    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed