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Document Control Specialist

LGM PHARMA SOLUTIONS LLC

Document Control Specialist

Irvine, CA
Full Time
Paid
  • Responsibilities

    PRIMARY DUTIES AND RESPONSIBILITIES:  

    • Administer and improve Document Control process that incorporates the use of a MASTERControl document management system as well as a complex paper based workflow, filing, and archiving process.
    • Work with personnel to manage implementation and rollout of MASTERControl document management system.
    • Examines documents to verify completeness and accuracy of data.
    • Confers with document originators to resolve discrepancies and compiles required changes to documents.
    • Administers the content quality and completeness of MASTERControl document management systems.
    • Maintains related files, prepares requests for reproduction of documents and prepares reports. 
    • Assistance with creation of specifications for raw materials and finished products.
    • Assistance with creation of Master batch records.
    • Assistance with creation of SOP’s.
    • Other related duties as required.

      QUALIFICATIONS: 

    • An Associates Degree (A.A.) or Bachelor's (B.A.) with at least three (3) years experience in Document Control.
    • Experience with the regulated, GMPs environment, terminology, and work flow.
    • Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations.
    • Strong communication skills, both written and verbal.