Guest Supply, LLC

  • Quality Assurance Specialist I

    Job Locations US-IN-Plainfield
    Posted Date 2 weeks ago(11/18/2019 1:40 PM)
    Job ID
    2019-2309
    # of Openings
    1
    Category
    Quality
  • Overview

    The Quality Assurance Specialist I will perform Quality Assurance (QA) activities to build, maintain, and improve the Company’s Quality Assurance Management Plan.  Must demonstrate independent judgment and make recommendations regarding business practices.

    Responsibilities

    • Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
    • Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.
    • Perform internal supplemental audits with supervision to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
    • Perform training and manage the Quality System’s Training Program.
    • Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
    • Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements with supervision.
    • Evaluate responses with supervision to deviation reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
    • Make changes to SOPs, policies, training materials, and other documents in the records management system.
    • Interface with various Divisions in problem resolution, and continual improvement.
    • Support manufacturing failure investigations.
    • Perform other duties as assigned.

    Qualifications

    • Bachelor’s Degree or equivalent relevant experience.
    • Minimum 1 year related experience working in a Food and Drug Administration (FDA) regulated pharmaceutical or cosmetic manufacturing environment.
    • Minimum 1 year experience training safety, quality and GMPs in a business setting.
    • Minimum 1 year of progressive experience in Quality Assurance
    • Demonstrable strong written and verbal communication skills.
    • Excellent organizational skills.  
    • Proven record of excellent documentation skills.
    • FDA & OSHA trained and familiar with current regulations.
    • Strong problem solving skills.
    • Technical software skills in Microsoft Office Suites required.
    • Work well under pressure and able to prioritize workloads.
    • Ability to perform risk assessment.
    • Experience fostering teamwork to get results.
    • Well organized and multi-task oriented.
    • Ability to work independently on multiple projects.
    • Ability to read, write and speak English competently.

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