• QA Validation Specialist III / Manager, QA Validation

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(4/22/2019 4:55 PM)
    Job ID
    2019-1224
    # of Openings
    1
    Category
    Quality
  • Overview

    The QA Validation Specialist III/Manager will collaborate with the Validation group and system/equipment owners to ensure the quality of products and compliance to internal procedures and external standards. Provides technical review and quality oversight of equipment, utility, process qualification/validation documents to support clinical and commercial manufacturing. Review, develop, and improve quality system procedures, specifications, and test methods. May support other elements of the quality system such as change control or deviations. This position will report to the Senior Director, Quality Assurance.

    Responsibilities

    •Participate on project teams as the QAV representative
    •Review and approve validation documentation: URS, validation plans, protocols, reports
    •Provide guidance on documentation of exceptional conditions or deviations encountered during execution of validations
    •Provide QA review of procedures related to validation activities
    •Support change controls which require validation activities
    •Review equipment lifecycle forms and associated validation/calibration requirements for accuracy and completeness
    •Review out of tolerance notifications and unscheduled maintenance work orders for impact on product, validation, calibration
    •Maintain and continuously improve quality system processes and procedures
    •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
    •Prior experience reviewing or executing a variety of equipment, utility, facilities and process validations (e.g. water systems, HVAC systems, compressed air and nitrogen, controlled temperature chambers)
    •Knowledge of computer system validation, cleaning validation, test method validation requirements desirable
    •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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