Quality Control Business Analyst 87391

OperationsSupport

• Lead the QC applicationimplementation and integration projects for the HoustonSite.
• Procure configure and maintain anycomputers instruments and equipment related to the QClabs.
• Work together with customers vendors andlocal and global teams to configure the application adapt to thelocal needs and document any applicationdeliverables.
• Configure instruments and devicesrelated to the implementation of QC systems andapplications.
• Act as system owner of the localQC systems.
• Author of QC Systems OperationalHandbook User Management Periodic Reviews / Maintenance and DisasterRecovery SOPs.
• Responsible for the QCapplications support (including system periodicreviews).
• Provide onsite support and trainingto system users.
• Proactively recognizepotential issues or problems and establish the necessary correctiveactions.
• Provide afterhours support as neededto resolve issues outside of normal businesshours.
• Continuously aware of new methodologiesrelated to automation information systems and is able to introducethem with limited supervisoryinput.
• Investigates and troubleshoot technicalproblems of increasing complexity related to QC systeminterfaces.
• Utilizes system documentation tosolve complex problems.
• Contribute to thedesign and implementation of new applications / solutions related tothe integrations of QC instruments to QC applications / systems toenable data transfer.
• Understand and complywith 21 CFR Part 11 regulations.
• Maintainssystem integrity and seeks performance and securityimprovements.

Projects

• Assistwith the planning and execution of integration projects involvingcomputerized systems changes and process improvements for the QClab.
• Execute test scripts (design executionsimulation etc.) with support and guidance from thesupervisor.
• Own change requests and completechange request tasks to support projectcompletion.
• Perform change requestassessments.

Deviations / RootCause Analysis

• Assist the Qualitydepartment with deviation investigations
• Assistwith the completion of CAPA actions
• Providestechnical input of QC lab systemsdeviations
• Participates in quality riskassessments

Documentation

• Review / reviseOIS and manufacturingrelated SOPs Functional Specifications andwork instructions as a result of CAPA equipment / process changeserror prevention activities etc.
• Review workorders generated by OIS
• Develop test andmaintain disaster recovery / applicationprocedures

Training

Remainup to date on all assigned training activities including SAPLearning Portal (>

95%)

Compliance Wire(no overdue) iComply (no overdue) and QSMRT (attend allsessions)

Provide training to endusers

application,projects,disasterrecovery