Location: Barceloneta, PR
Pay Rate: $22.69 / Hourly

Purpose:
The QA Systems 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.

Responsibilities:

• 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 events.
• Provide support to Quality Control, SCM and manufacturing personnel on day today 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.

Qualifications:

• Bachelor Degree with a minimum of two (2) years of experience in Quality or Quality Systems.
• Systems Experience (SAP, ERP, EBR, POMSnet and/or FLowstream).
• Knowledgeable in LIMS system.
• 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 in order to comply with business needs.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 22.69/hr.