Quality Systems Analyst (Sap Material Master/Lims/Sap/Erp) (Pharma/Medical Device)

Systems Ally

  • Barceloneta, PR
  • Autónomo
  • Tiempo completo
  • Hace 2 días
*Candidate must be able and have the flexibility to work OT and Weekend due to business needs.**1st Shift**General Position Summary/Purpose: 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
*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 managementopportunities.
  • Perform system maintenance activities to assure that it is updated to the currentproduct specifications and requirements.
  • Create and maintain Inspection Plans synchronized within the applicable systemsfor raw material, commodities, manufacturing products per approvedspecification.
  • Create and maintain master data for raw materials, commodities andmanufacturing 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 Flow stream)- 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 bussiness needs.
*What are the top 3-5 skills, experience or education required for this position?*
  • Fully Billingual
  • Bachelor Degree.
  • Experience Requirements:- Minimum two (2) years of experience in Quality or Quality Systems Systems Experience (SAP & SAP Material Master updates).
*Daily Work Schedule Expectations*1 st shiftJob Type: ContractPay: $20.00 - $22.00 per hourExpected hours: 40 per weekEducation:
  • Bachelor's (Preferred)
Experience:
  • Quality systems: 2 years (Preferred)
  • Pharma or medical device or biotech industry: 2 years (Preferred)
  • SAP: 2 years (Preferred)
  • SAP Material Master updates: 2 years (Preferred)
  • change control assessment process: 2 years (Preferred)
  • Electronic Batch Record (EBR): 2 years (Preferred)
Ability to Commute:
  • Barceloneta, PR 00617 (Preferred)
Work Location: In person

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