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Elkton

    Quality Specialist - Elkton, VA, United States - Integrated Resources, Inc

    Integrated Resources, Inc
    Integrated Resources, Inc Elkton, VA, United States

    1 day ago

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    Description

    Job Title: Quality Specialist - I (Assistant)

    Job Location: Elkton, VA

    Job Duration: 12+ months

    Job Description:

    · The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.

    · The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.

    · The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews.

    · Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge.

    · May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements.

    · Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols. Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.

    · The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections.


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