• Quality Assurance Specialist II Operations

    Job Locations US-MA-Bedford
    Posted Date 8 months ago(3/29/2018 8:58 AM)
    Job ID
    2018-1063
    # of Openings
    1
    Category
    Quality
  • Overview

    Works with other departments to ensure the quality of products and compliance to internal procedures and external standards. Provides quality oversight to GMP processes through walkthroughs and review of executed batch records and associated documentation, and review of analytical data.  Continuously improves quality system procedures related to these tasks. 

    Responsibilities

    • Review and release Master Batch Records for production
    • Release and reconcile labeling for production
    • Review analytical data supporting raw material release, drug product release and stability testing for accuracy and completeness
    • Review executed batch records and supporting documents for accuracy and completeness
    • Collaborate with manufacturing to ensure comments, corrections, and deviations are properly documented
    • Ensure deviations are referenced and completed prior to batch disposition
    • Review and approve minor deviations associated with batch records
    • Maintain schedule for batch record reviews and batch disposition
    • Monitor and trend batch record errors and batch review/disposition times
    • Perform line clearance
    • Perform walkthrough of GMP areas to support inspection readiness
    • Review documentation associated with receiving, inspection, and testing of raw materials, and disposition raw materials
    • Identify opportunities to improve quality processes/procedures and support continuous improvement initiatives
    • Perform other quality assurance duties as assigned

    Qualifications

    •Bachelor’s degree in relevant scientific discipline
    •Minimum three years of experience in pharmaceutical, biotech or medical device industry with some experience reviewing manufacturing batch records
    •Excellent organizational skills and attention to detail
    •Good verbal and written communication skills
    •Strong interpersonal skills
    •Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
    •Ability to work independently and effectively collaborate with others
    •Working knowledge of FDA and international regulations and GxP guidelines

     

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