Jobs

Description

Job Title: Associate, QA Systems Analyst

Division: Operations

Department: QA - Documentation

Reports to: QA Documentation Section Manager

Job Responsibilities:

List all major responsibilities of the position in order of importance and priority to the overall job. Describe the outcome that must be produced in accomplishing the job. Each supports the overall purpose of the job.

• 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.
• 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:

List the minimum education, skills, requirements, practical knowledge, etc., needed to qualify.

• Educational requirements: Bachelor Degree.

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.

Experience Required:

List the minimum experience needed to qualify. Please include the position titles or descriptions of experience and required years.

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.

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:

• Maintain integration of data requirements for quality systems (SAP, Thermo LIMS, MES, ERP, etc).
• Perform assessment and coordination for data management opportunities.
• 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.)
• Perform system maintenance activities to ensure that it is updated to the current product specifications and requirements
• Monitor systems data interface for troubleshooting and correction of exceptions log events

Experience Level = 3-5 Years