Job Title: Associate, QA Systems Analyst

Job 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 ensure that it is updated to the current product
specifications and requirements.[s]
[/s]• Create and maintain Inspection Plans synchronized within the applicable systems for raw
material, commodities, and 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.

Knowledge/ Education Required:
• Educational requirements: Bachelor Degree on information systems/supply chain.
Technical Skills:
• 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 is desirable.
• Ability to manage multiple and changing priorities in order to comply with business needs.
• Systems Experience (SAP, ERP, EBR, POMSnet and/or Flowstream)
- Knowledgeable in LIMS system.
• Should possess strong knowledge/application in PC's, software applications such as Excel,
MS Word and Access.
• Proficient knowledge of Outlook and Windows. MES Acknowledge is needed.
Advanced problem solving related to interaction of the systems and or data capability

Experience Required:
• 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. MES and supply chain experience.
Computer system experience with commercial software packages, database, and report generation.
Advanced experience using ThermoSample Manager and/or SAP is desired.
Computer system experience- use of commercial software packages to develop spreadsheets, databases, adhoc inquiries, and reports.

Quality, Safety & Environmental Responsibilities:
Working conditions, frequency
The work is fast paced and is continuously changing environment. The incumbent is subject to
working with multiple priorities and under reasonable pressure due to the nature and function of the
area.

What are the top 3-5 skills, experience or education required for this position:
1. Individual is responsible for the implementation and maintenance of quality static data in ThermoSampleManager LIMS and SAP data software applications supporting Quality, QC laboratories and Production in a way that enhances the business process.
2. Create, maintain, and manage the SAP Quality Module static data for all new and modified projects,
including materials, inspection lot, inspection plans, recipes and lot release specifications
3. Create and maintain master data for raw materials, commodities and manufacturing products (Master Recipes, Bill of Materials, etc.)
4. Provide trouble shooting and alternate methods to ensure all quality data is in the systems to meet
manufacturing schedules.

**Weil Group is proud to be an Equal Employment Opportunity Employer.*