• Quality Assurance Specialist II, Deviations

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(3/28/2018 5:56 PM)
    Job ID
    # of Openings
  • Overview

    Works with other departments to ensure the quality of products and compliance to internal procedures and external standards. Provides oversight to deviation, investigation and CAPA systems. Performs or facilitates investigations of quality events. Continuously improves quality system procedures related to these tasks. 


    •Maintain deviation, investigation and CAPA procedures and logs
    •Perform, review and approve minor deviations
    •Facilitate root cause analysis investigations of major and critical deviations
    •Coordinate or perform investigations of product complaints and implement corrective/preventive actions
    •Assign CAPAs and collaborate on determining actions to address root cause
    •Lead cross-functional meetings to review status of deviations/investigations/CAPAs
    •Monitor and trend approval times 
    •Evaluate the effectiveness of CAPAs
    •Identify opportunities to improve quality processes/procedures and support continuous improvement initiatives
    •Perform other quality assurance duties as assigned


    •Bachelor’s degree in relevant scientific discipline
    •Minimum three years of experience in pharmaceutical or biotech industry, experience performing investigations preferred
    •Working knowledge of FDA and international regulations and GxP guidelines
    •Excellent organizational skills and attention to detail
    •Strong technical writing capability
    •Effective communication skills
    •Proficiency in MS Office, Excel, PowerPoint etc.
    •Ability to work independently and effectively collaborate with others


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