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    Documentation Specialist I - Fremont, United States - Fladger Assoc. Inc.

    Fladger Assoc. Inc.
    Fladger Assoc. Inc. Fremont, United States

    6 days ago

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    Description

    Job Description

    Job DescriptionFremont, CAContract Duration: 5-24 monthsRate: Negotiable

    Responsibilities:

    • Excellent employment opportunity for a Documentation Specialist I in the Fremont, CA area.
    • This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility.
    • The position performs duties under limited supervision and according to standard operating and manufacturing procedures.
    • It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.
    • Independently executes (paper/electronic) batch record review
    • Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.

    Experience:

    • Requires a Bachelor's Degree, preferably in the Life Science Field plus a minimum of 2 years of professional experience in a GMP environment.
    • In lieu of a Bachelor's Degree, will consider an Associate's Degree plus 4 years of professional experience in a GMP environment or clean room assembly environment.
    • Demonstrated proficiency in MS Office programs and associated computer programs.
    • Technical knowledge of manufacturing systems, methods and procedures.
    • Must have excellent written and verbal communication skills.
    • Awareness and understanding of Manufacturing processes
    • Required skills: BATCH RECORD REVIEW, DOCUMENTATION, MANUFACTURING PROCESSES, GMP, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
    • Additional Skills: ASSEMBLY, LIFE SCIENCE, MS OFFICE, BATCH RECORD, BATCH RECORDS, INVENTORY, MICROSOFT OFFICE, PROCESS IMPROVEMENT, QA, EXCELLENT WRITTEN
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