Halo Pharmaceuticals

  • Quality Assurance Compliance Specialist

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Quality Assurance Compliance Specialist will fill a key compliance and regulatory position within a growing contract manufacturing company.  The individual will act as the primary point of contact for suppliers / vendors in Halo’s effort to coordinate with service providers. Provide appropriate documentation to complete vendor qualification process and maintain the vendor qualification program at the Halo, Whippany NJ site.  Responsible for reviewing vendor inspection questionnaires, supporting documentation and performing risk assessments.  This activity may require frequent follow-up activities.  The individual will be responsible for updating master sourcing list and maintaining approved vendor  files.

    Responsibilities

    The individual will be expected to perform a number of tasks associated with the compliance / regulatory requirements.  Responsibilities include audit preparation prior to customer and regulatory audits.  The individual will support the QA Compliance Management with regard to preparation and conducting Regulatory Authority audits. Will participate and perform internal audits of corporate systems.

    In addition to the general responsibilities outlined above, the general Responsibilities include:

    • Coordinate Meetings
    • Participate in Audit preparation
    • Interface with clients and internal departments
    • Assist with CAPA Management
    • Approve Calibrations PRs
    • Drive Change Request
    • Assist with client audit tours
    • Review and Prepare Audit Reports
    • Provide support to the Documentation Management Group
    • Assist QA Compliance Management with Compliance / Quality / Regulatory Gap Assessments
    • Implement new vendor management systems / program
    • Serve as main contact for supplier and vendor qualification
    • Create TSE/BSE statements as needed
    • Assist QA and CCR Managers with progressing Change Request
    • General regulatory / compliance tasks in support of Halo’s clients and regulatory inquiries
    • Other duties as assigned.

     

    Qualifications

     

     

    Qualifications:

    • 2-4 years of pharmaceutical experience
    • 2 years’ experience in Quality Compliance and/or Quality Systems
    • Able to work in a fast paced environment
    • Self-Starter, can perform expected task with little oversight
    • BS Degree Science, Engineering, and/or Health Science related; will consider AS Degree with comparable experience
    • Ability to lift up to 30lbs
    • Ability to move about to access and transport files within the facility
    • Ability to be sedentary 50% of time

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