Associate Quality Analyst I

Job Title : Associate QA System Analyst

Location : Barceloneta PR

Duration : 12 Months

Pay Range : $20 / hr - $22.06 / hr

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 [1]the-art knowledge to constantly improve the systems and to create cost effective solutions to problems.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 exceptionslog 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 :

List required and preferred qualifications (up to 10). Include education, skills and experience.

Educational requirements : Bachelor Degree.

Experience Requirements : - Minimum 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 andoral 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