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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

QA Analyst (Systems)

Barceloneta, Barceloneta, Puerto Rico Req ID 2210714 Category Quality Assurance Division AbbVie

The QA System Analyst ensures that the SAP system static data is updated per current specification/requirements and the EBR (POMSnet) system recipes are compliant to current specification/requirements. Follow appropriate policies, industry standards, government regulations, plant and departmental procedures to design implement and maintain the systems. Provides state-of-the-art knowledge to constantly improve the systems and to create cost-effective solutions to problems.


  • Maintain integration of data requirements for quality systems (SAP, Thermo LIMS, MES, ERP, etc). Perform assessment and coordination for data management opportunities.
  • Perform system maintenance activities to assure that it is updated to the current product specifications and requirements.
  • Create and maintain Inspection Plans synchronized within the applicable systems for raw material, commodities, manufacturing products per approved specification.
  • Create and maintain master data for raw materials, commodities and manufacturing products (Master Recipes, Bill of Materials, etc.)
  • Monitor systems data interface for troubleshooting and correction of exceptions log events.
  • Provide support to Quality Control, SCM and manufacturing personnel on day to day Electronic Batch Record (EBR) execution.
  • Create and maintain Product Master Recipes and Bill of Materials for manufacturing products. Communicate with accounting, MES and Supply Chain groups for recipe generation and updates.
  • Create Change Requests for changes in master data, inspection plans and master recipes.
  • As a Quality representative, may participate in the Change Review Board (CRB) and change control assessment process.
  • Request and/or approve as SME assessment of Impact forms for raw materials, commodities and manufacturing specifications for User Site Effective.

  • Bachelor Degree with at least two (2) years of experience in Quality or Quality Systems is required.
  • Must have experience and advanced knowledge in SAP Manufacturing System, ERP, EBR, POMSnet and/or FLowstream.
    Knowledgeable in LIMS system.
  • Knowledge in requesting and/or approving assessment of Impact forms for raw materials, commodities, and manufacturing specifications.
  • Must be able to communicate effectively in English and Spanish (both written and oral skills).
  • Good interpersonal skills, teamwork, analytical and problem solving skills.
  • Experience in pharmaceutical manufacturing process desirable.
  • Should possess strong knowledge/application in PC's, software applications such as Excel, MS Word and Access.
  • Proficient knowledge of Outlook and Windows.
  • Ability to manage multiple and changing priorities.
Significant Work Activities: Keyboard use (greater or equal to 50% of the workday)Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time

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