• Manufacturing Operations Associate

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1335
    Category
    Manufacturing
  • Overview

    The Manufacturing Operations Associate is responsible for aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).

    Responsibilities

     

    • Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
    • Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
    • Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
    • Represents department in cross-functional teams, projects and GXP-related problem resolution.
    • Posts weights and shipping charges, and prepares goods for final shipment.
    • Prepares and maintains records of merchandise shipped.
    • Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.
    • Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
    • Other duties as assigned
    • Applies job skills and company policies and procedures to complete a wide range of tasks.
    • Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
    • Normally receives general instructions on routine work, detailed instructions on new assignments.
    • Uses ability as a skilled specialist in accordance with company policies and procedures to compete complex tasks in creative and effective ways.
    • Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making routine recommendations.
    • May determine methods and procedures on new assignments and may provide guidance to other support personnel.
    • Ability to be flexible and support all functions by readily responding to changing circumstances (i.e.shift changes) and business needs.

     

     

     

     

     

    Qualifications

    • Associate’s or Medical Technical degree or equivalent.
    • Typically 2 years related experience in CGMP/FDA regulated industry or 1 year with Medical Technical degree.
    • Proficient in MS Office applications.

     

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