• Quality Assurance Specialist III, Operations

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(3/28/2018 5:57 PM)
    Job ID
    2018-1062
    # 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, 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
    •Ensure out of specification investigations and deviations are referenced and completed prior to data disposition
    •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, data reviews and batch disposition
    •Monitor and trend batch record errors, batch review and data review cycle 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 five years of experience in pharmaceutical/biotech industry, prior experience working in chemistry lab preferred
    •Understanding of analytical methods, QC and data review
    •Familiar with data generated by various types of equipment – HPLC, GC, KF, UV-Vis
    •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.
    •Working knowledge of Empower software
    •Ability to work independently and effectively collaborate with others
    •Knowledge of FDA and international regulations and GxP guidelines

     

     

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